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Sunday, May 30, 2010

Fw: (Fresh Produce) Digest for freshproduce@googlegroups.com - 13 Messages in 9 Topics

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From: freshproduce+noreply@googlegroups.com
Date: Fri, 28 May 2010 21:34:01 +0000
To: Digest Recipients<freshproduce+digest@googlegroups.com>
Subject: (Fresh Produce) Digest for freshproduce@googlegroups.com - 13 Messages in 9 Topics

Group: http://groups.google.com/group/freshproduce/topics

    Big Apple <Ernestoman@yahoo.com> May 28 08:25AM -0700 ^
     
    May 27, Walletpop.com – (National) Wooden pallets could be poisoning
    our food, consumer group's test show. A national consumer group said
    the U.S. Food and Drug Administration should set minimum sanitary and
    safety standards for pallets used to transport food, after tests
    revealed the presence of bacteria that cause food poisoning. "We
    believe it is essential to ensure that pathogens are not introduced at
    any step along the food transport system, from farm to fork," the
    executive director of the National Consumers League (NCL) said in a
    statement. The recommendations follow recent tests conducted by the
    NCL on pallets to determine whether they may be carriers of pathogens.
    The NCL tested pallets for a number of food-borne pathogens, including
    E. coli and Listeria, and found 10 percent of the wooden pallets
    tested positive for E. coli (though not the most virulent strain, E.
    coli O157:H7). In addition to the presence of E. coli, 2.9 percent of
    the wood pallets tested positive for Listeria. Half of these, when
    further tested, contained Listeria monocytogenes, one of the most
    virulent pathogens. This strain is linked to a 20 to 30 percent rate
    of clinical infection resulting in death, and causes approximately
    2,500 illnesses and 500 deaths in the United States every year.
    Listeriosis is also more likely to cause death than any other food-
    borne bacterial pathogen. "With approximately two billion pallets
    currently in circulation in the United States, the presence of
    dangerous pathogens on even a small percentage of those pallets
    presents a potential threat to the safety of the food supply," the NCL
    executive director wrote to the FDA. Although both types of pallets
    tested positive for pathogens, wooden pallets contained far more for a
    number of reasons. Unlike plastic, wooden pallets absorb water, harbor
    bacteria and are difficult to fully clean, making it easier for them
    to contaminate food. The NCL's test also revealed wood pallets are
    more likely to be stored outside and exposed to weather, rodents, bird
    droppings and insects. Splinters on wooden pallets can also damage
    packaging, creating an opening for pathogens. In a just-issued report
    prepared for the FDA, Eastern Research Group, Inc. highlights the use
    of "good quality pallets" as a preventive measure. The agency has said
    it will use the report to inform the development of new rules to
    increase the safety of food during transport.
    Source: http://www.walletpop.com/blog/2010/05/27/wooden-pallets-could-be-poisoning-our-food-consumer-groups-tes/

     

    Tom <tckarst@gmail.com> May 28 08:40AM -0700 ^
     
    This story line has been out there for a while; I wonder where the
    funding for the consumer group comes form..
     
    TK
     

     

    Big Apple <Ernestoman@yahoo.com> May 28 09:52AM -0700 ^
     
    ( Apparently they did their own research and this is the recent report
    although other stories may have examined the problem. Eleanor
    Roosevelt became a lifelong supporter of the National Consumers'
    League. Looks like they get funding from GE, Bureau of Justice
    Assistance in the U.S. Department of Justice, AT&T, MasterCard and
    others. It's the oldest org of it's kind. But the question did enter
    my mind if it was a possible shill. Doesn't appear to be. They've been
    in the consumer food research activity field a long time as well as
    others. I'm sure the organization could expand on this study for you.)
    BA
     
    NCL calls on FDA to regulate industry after tests reveal hidden
    pathogens on pallets used to transport food
     
     
    Release Date: May 26, 2010
    Contact: 202-835-3323, media@nclnet.org
     
    Washington, DC – In the wake of the recent recall of E. coli-tainted
    romaine lettuce, the nation's oldest consumer organization, the
    National Consumers League (NCL), is urging the U.S. Food and Drug
    Administration (FDA) to set minimum sanitary and safety standards for
    the "unregulated but crucial" pallets that are used to transport food
    throughout the United States.
     
    The move by NCL comes following recent exploratory tests conducted by
    the organization on pallets to determine whether they are potential
    carriers of pathogens, as concerns grow about the link between pallets
    and contamination of food and pharmaceuticals. The consumer group
    tested pallets for foodborne pathogens, including E. coli and
    Listeria. The findings were alarming: 10 percent of the wood pallets
    tested had E. coli present (though not the most virulent strain, E.
    coli O157:H7). In a letter to the FDA, NCL described the results of
    its exploratory testing of wood and plastic pallets used to transport
    food in the greater Houston, Texas and Miami/Tampa, Florida, areas.
    Testing was conducted in late April and included 70 wood pallets and
    70 plastic pallets in total. NCL shipped the samples overnight to an
    independent microbiology lab that provides testing services for a wide
    array of commercial, industrial, regulatory, and law enforcement
    clients.
     
    [Read NCL's letter to FDA; http://nclnet.org/images/PDF/fda%20palletsletter.pdf]
    [View positive samples from testing;
    http://nclnet.org/images/PDF/ncl%20pallet%20testing%20positive%20results%20identification.pdf]
     
    "We believe it is essential to ensure that pathogens are not
    introduced at any step along the food transport system, from farm to
    fork. Our testing of pallets has shown that these relatively
    unregulated but crucial parts of the food transportation system can
    and do harbor dangerous pathogens that could potentially contaminate
    the food supply," said Sally Greenberg, the League's Executive
    Director.
     
    In addition to the presence of E. coli, 2.9 percent of the wood
    pallets tested positive for Listeria, and half of these, when further
    tested, contained Listeria monocytogenes, one of the most virulent
    foodborne pathogens. This strain of Listeria is linked to a 20 to 30
    percent rate of clinical infections resulting in death and causes
    approximately 2,500 illnesses and 500 deaths in the United States
    every year. Listeriosis is more likely to cause death than any other
    foodborne bacterial pathogen. Of the 70 plastic pallets tested, 1 – or
    1.4 percent – came back positive for E. coli. None of the other
    plastic pallets tested positive for pathogens.
     
    Finally, high aerobic plate counts, which reflect unsanitary
    conditions of the pallets, were found on approximately one third of
    the wood pallets and one fifth of the plastic pallets.
     
    As the recent outbreak of E. coli underscores, the threat of foodborne
    illness remains a serious concern in the United States.
     
    "Looking at the safety of pallets is crucial. Even if farmers,
    manufacturers, retailers, and consumers were all to follow food safety
    plans and practices to the letter, the introduction of dangerous
    pathogens into the food supply during transport could negate these
    efforts…With approximately two billion pallets currently in
    circulation in the United States, the presence of dangerous pathogens
    on even a small percentage of those pallets presents a potential
    threat to the safety of the food supply," wrote Greenberg in her
    letter to the FDA.
     
    Several different aspects of pallet use and storage present potential
    food safety concerns. If a pallet is absorptive – i.e., has the
    capacity to absorb water and harbor bacteria – or difficult or
    impossible to fully clean, it could contaminate food products like
    fresh produce or meat. A pallet that carries raw seafood on ice to a
    given destination, then heads of lettuce or apples to the next, could
    potentially contaminate that produce and lead to foodborne illness. In
    a just-issued report prepared for the FDA, Eastern Research Group,
    Inc. highlights the use of "good quality pallets" as a preventive
    measure. The agency has said it will use the report to inform the
    development of new rules to increase the safety of food during
    transport.
     
    Furthermore, regardless of the materials from which it is made, any
    pallet that is not properly cleaned between trips increases the
    likelihood of cross-contamination. Storing a pallet outside, in
    unsanitary areas, in places accessible to vermin, or near potential
    contaminants increases the chances that the pallet could harbor
    dangerous pathogens. In conducting our testing, we observed that wood
    pallets – which we found to have a higher incidence of pathogens – are
    more often stored outside and exposed to weather, rodents, bird
    droppings, and insects. Among additional considerations is the use of
    damaged wood pallets; splinters or sharp points can damage the
    packaging of products, creating an entryway for pathogens from which
    sealed products would otherwise be protected.
     
    NCL's findings build on the growing concern about the potential
    dangers of unregulated pallets to consumers. In January of this year,
    McNeil Consumer Healthcare issued a recall of several of its over-the-
    counter products reported to have a moldy odor and that, in some
    individuals, were thought to have caused gastrointestinal distress. In
    a press release dated January 15, the company stated: "McNeil Consumer
    Healthcare has determined that the reported uncharacteristic smell is
    caused by the presence of trace amounts of a chemical called 2,4,6-
    tribromoanisole (TBA). This can result from the breakdown of a
    chemical that is sometimes applied to wood that is used to build wood
    pallets that transport and store product packaging materials." The FDA
    issued the same statement on its Web site.
     
    NCL is urging the FDA to do its own testing and set standards that
    will help to ensure that pallets are cleaned and stored properly, thus
    minimizing the possibility that they will be implicated in the spread
    of foodborne illness.
     
    ###
     
    About the National Consumers League
     
    Founded in 1899, the National Consumers League is America's pioneer
    consumer organization. Its mission is to protect and promote social
    and economic justice for consumers and workers in the United States
    and abroad. NCL is a private, nonprofit membership organization. For
    more information, visit www.nclnet.org.
     
    Source
    http://nclnet.org/newsroom/press-releases/404-ncl-calls-on-fda-to-regulate-industry-after-tests-reveal-hidden-pathogens-on-pallets-used-to-transport-food
     

     

    Tom Karst <tkarst@thepacker.com> May 28 08:34AM -0700 ^
     
    Tom Karst has sent you a link to a blog:
     
    Restaurant Industry Outlook Remained Positive as the Restaurant
    Performance Index Stood Above 100 in April Same-store sales and traffic
    levels softened in April; Operators remain optimistic about sales
    growth and the economy
     
    Blog: Fresh Produce Discussion Blog
    Post: Restaurant Industry Outlook Remained Positive as the Restaurant
    Performance Index Stood Above 100 in April
    Link:
    http://freshproducetalk.blogspot.com/2010/05/restaurant-industry-outlook-remained.html
     
    --
    Powered by Blogger
    http://www.blogger.com/

     

    Big Apple <Ernestoman@yahoo.com> May 28 08:39AM -0700 ^
     
    (Life involves risks they say.) BA
     
    May 26, Food Poison Journal – (Florida) Chef at Miami area Chili's
    worked while ill with typhoid fever. A cook at a popular Bayside,
    Florida Chili's Grill and Bar apparently worked for a period of time
    while ill and contagious with Salmonella typhi, the strain that causes
    typhoid fever, NBC Miami reported May 24. While no patron illnesses
    have been reported thus far, hundreds of people may have consumed food
    prepared by the cook while ill. The symptoms of typhoid fever may
    include constipation, cough, sore throat, headache, and a rash on the
    infected individual's chest, as well as the slowing of the heartbeat
    and enlargement of the liver and spleen (Mayo Clinic, 2007, April 12).
    The onset of symptoms usually occurs between 5 and 21 days after
    ingestion of Salmonella typhi bacteria.
     
    http://www.foodpoisonjournal.com/2010/05/articles/food-poisoning-watch/chef-at-miami-area-chilis-worked-while-ill-with-typhoid-fever/
     

     

    Big Apple <Ernestoman@yahoo.com> May 28 08:29AM -0700 ^
     
    May 26, Gaithersburg Gazette – (Maryland) The University of Maryland's
    M Square research park in College Park soon might become a crucial hub
    for ensuring global food safety. The university has struck a
    partnership with Waters Corp. of Milford, Massachusetts, to build and
    operate the first stateside laboratory for training foreign food
    producers that export to the U.S. The International Food Safety
    Training Laboratory, is expected to open in July 2011. About 200
    foreign scientists will be taught there each year by members of the
    Joint Institute for Food Safety and Applied Nutrition, a collaborative
    program between the university and the U.S. Food and Drug
    Administration (FDA). The lab will have a staff of five full-time
    workers. Waters Corp., which develops scientific strategies for
    regulatory compliance, is investing $4 million in technology and
    curriculum design for the laboratory. "The goal is to improve food
    safety for customers in the U.S. and, in turn, domestically for the
    producers' countries," said the program's associate director. He said
    the training will be based on the training given at the FDA. With
    imports accounting for 15 percent of the U.S. food supply, the nation
    needs a better way of ensuring food safety than border inspections,
    the associate director said. "The demand for expertise — especially
    the hands-on variety — far outstrips current technical capacity in
    many countries, driven in part by U.S. importers and retailers seeking
    safety assurances," he said in a statement. Instead,
    this private-public partnership will train foreign food producers to
    perform their own analyses according to FDA regulations, he said. "The
    FDA couldn't make this deal because of governmental restrictions and
    regulations," he added.
    Source: http://www.gazette.net/stories/05262010/busiplo164440_32559.php

     

    Tom <tckarst@gmail.com> May 28 08:38AM -0700 ^
     
    Interesting concept - I wonder how much of a market they will have..
    producers in other countries may feel they have sufficient
    infrastructure to get the job done
     
    Tk
     

     

    Big Apple <Ernestoman@yahoo.com> May 28 08:13AM -0700 ^
     
    [Federal Register: May 28, 2010 (Volume 75, Number 103)]
    [Notices]
    [Page 29969-29972]
    From the Federal Register Online via GPO Access [wais.access.gpo.gov]
    [DOCID:fr28my10-27]
     
    -----------------------------------------------------------------------
     
    DEPARTMENT OF AGRICULTURE
     
    Animal and Plant Health Inspection Service
     
    [Docket No. APHIS-2010-0047]
     
     
    Environmental Impact Statement; Determination of Nonregulated
    Status of Sugar Beet Genetically Engineered for Tolerance to the
    Herbicide Glyphosate
     
    AGENCY: Animal and Plant Health Inspection Service, USDA.
     
    ACTION: Notice of intent to prepare an environmental impact statement
    and proposed scope of study.
     
    -----------------------------------------------------------------------
     
    SUMMARY: We are advising the public that the Animal and Plant Health
     
    [[Page 29970]]
     
    Inspection Service plans to prepare an environmental impact statement
    in connection with a court-mandated evaluation of the potential
    impacts
    on the human environment associated with the Agency's determination
    of
    nonregulated status for a Monsanto/KWS SAAT AG sugar beet line,
    designated as event H7-1. This notice identifies the environmental
    and
    interrelated economic issues raised by the Court and other potential
    issues that we may include in the environmental impact statement and
    requests public comment to further delineate the scope of the issues
    and reasonable alternatives.
     
    DATES: We will consider all comments that we receive on or before
    June
    28, 2010.
     
    ADDRESSES: You may submit comments by either of the following methods:
    Federal eRulemaking Portal: Go to http://
    www.regulations.gov/fdmspublic/component/
    main?main=DocketDetail&d=APHIS-2010-0047 to submit or view public
    comments and to view supporting and related materials available
    electronically.
    Postal Mail/Commercial Delivery: Please send one copy of
    your comment to Docket No. APHIS-2010-0047, Regulatory Analysis and
    Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118,
    Riverdale, MD 20737-1238. Please state that your comment refers to
    Docket No. APHIS-2010-0047.
    Reading Room: You may read any comments that we receive on this
    docket in our reading room. The reading room is located in room 1141
    of
    the USDA South Building, 14th Street and Independence Avenue, SW.,
    Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
    Monday through Friday, except holidays. To be sure someone is there
    to
    help you, please call (202) 690-2817 before coming.
     
    FOR FURTHER INFORMATION CONTACT: Dr. Andrea Huberty, Biotechnology
    Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
    20737-1236; (301) 734-0485.
     
    SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340,
    ``Introduction of Organisms and Products Altered or Produced Through
    Genetic Engineering Which Are Plant Pests or Which There Is Reason to
    Believe Are Plant Pests,'' regulate, among other things, the
    introduction (importation, interstate movement, or release into the
    environment) of organisms and products altered or produced through
    genetic engineering that are plant pests or that there is reason to
    believe are plant pests. Such genetically engineered organisms and
    products are considered ``regulated articles.'' The regulations in
    Sec. 340.6(a) provide that any person may submit a petition to the
    Animal and Plant Health Inspection Service (APHIS) seeking a
    determination that an article should not be regulated under 7 CFR
    part
    340. Paragraphs (b) and (c) of Sec. 340.6 describe the form that a
    petition for a determination of nonregulated status must take and the
    information that must be included in the petition.
    On October 19, 2004, APHIS published a notice in the Federal
    Register (69 FR 61466-61467, Docket No. 04-075-1) announcing receipt
    of
    a petition from Monsanto/KWS SAAT AG requesting a determination of
    nonregulated status under 7 CFR part 340 for sugar beet (Beta
    vulgaris
    ssp. vulgaris) designated as event H7-1, which has been genetically
    engineered for tolerance to the herbicide glyphosate. The petition
    stated that this article should not be regulated by APHIS because it
    does not present a plant pest risk. APHIS also announced in that
    notice
    the availability of a draft environmental assessment (EA) for the
    proposed determination of nonregulated status. Following review of
    public comments and completion of the EA, we published another notice
    in the Federal Register on March 17, 2005 (70 FR 13007-13008, Docket
    No. 04-075-2), advising the public of our determination, effective
    March 4, 2005, that the Monsanto/KWS SAAT AG sugar beet event H7-1
    was
    no longer considered a regulated article under APHIS regulations in 7
    CFR part 340.
    On September 21, 2009, the U.S. District Court for the Northern
    District of California issued a ruling in a lawsuit filed by two
    organic seed groups and two nonprofit organizations challenging our
    decision to deregulate sugar beet event H7-1 (referred to in the
    lawsuit as Roundup Ready[reg] sugar beet), pursuant to the National
    Environmental Policy Act (NEPA) of 1969, as amended (42 U.S.C. 4321
    et
    seq.), the Administrative Procedure Act, and the Plant Protection
    Act.
    Under the provisions of NEPA, agencies must examine the potential
    environmental impacts of proposed Federal actions. The Court ruled
    that
    APHIS' EA failed to consider certain environmental and interrelated
    economic impacts. As a result, the Court stated that APHIS is
    required
    to prepare an environmental impact statement (EIS). Accordingly,
    APHIS
    plans to prepare an EIS. In doing so, APHIS will utilize as
    appropriate
    any environmental analysis provided by the Environmental Protection
    Agency (EPA) and other data or analysis prepared by other agencies.
    APHIS has requested that EPA serve as a cooperating agency. This
    notice
    identifies potential issues and reasonable alternatives that we are
    considering addressing, and requests public comment on the inclusion
    of
    these or related issues and alternatives in the EIS.
    Management practices for organic sugar beet, conventional sugar
    beet, and glyphosate-tolerant sugar beet. What are the management
    practices and associated costs of establishing, growing, harvesting,
    and marketing sugar beet, including selling prices and premiums for
    the
    various types of sugar beet? What crop rotation regimes are used with
    sugar beet?
    Production levels of organic and conventional sugar beet, Swiss
    chard, and table beet by region, State, and county. What is the
    acreage
    of cultivated, volunteer, or feral sugar beet? What is the acreage of
    Swiss chard and table beet? Which regions of the country may be
    affected as a result of a determination of nonregulated status for
    glyphosate-tolerant sugar beet? What are the potential impacts on
    adjacent, nonagricultural lands such as natural areas, forested
    lands,
    or transportation routes that may result from the use of glyphosate-
    tolerant sugar beet?
    Potential impacts of glyphosate-tolerant sugar beet cultivation
    on
    livestock production systems. What are the potential impacts of
    glyphosate-tolerant sugar beet cultivation on conventional and
    organic
    livestock production systems?
    Potential impacts on food and feed. Does glyphosate affect the
    socioeconomic value of food or feed or its nutritional quality? What
    are the impacts, if any, on food or feed socioeconomic value or its
    nutritional quality from the use of glyphosate?
    Differences in weediness traits of conventional sugar beet versus
    glyphosate-tolerant sugar beet. What are the differences, if any, in
    weediness traits of conventional sugar beet versus glyphosate-
    tolerant
    sugar beet under managed crop production systems, as well as in
    unmanaged ecosystems?
    Occurrence of common and serious weeds found in organic sugar
    beet
    systems, in conventional sugar beet systems, and in glyphosate-
    tolerant
    sugar beet systems. What are the impacts of weeds, herbicide-tolerant
    weeds, weed management practices, and unmet weed management needs for
    organic and conventional sugar beet cultivation? How may the weed
    impacts
     
    [[Page 29971]]
     
    change with the use of glyphosate-tolerant sugar beet?
    Management practices for controlling weeds in organic sugar beet
    systems, in conventional sugar beet systems, and in glyphosate-
    tolerant
    sugar beet systems. What are the potential changes in crop rotation
    practices and weed management practices for control of volunteer
    sugar
    beet or herbicide-tolerant weeds in rotational crops that may occur
    with the use of glyphosate-tolerant sugar beet? What are the
    potential
    effects on sugar beet stand termination and renovation practices that
    may occur with the use of glyphosate-tolerant sugar beet?
    Cumulative impact on the development of glyphosate-resistant
    weeds.
    What glyphosate-resistant weeds have been identified and what is
    their
    occurrence in crops and in non-crop ecosystems? How would the
    addition
    of glyphosate-tolerant sugar beet impact the occurrence of glyphosate-
    resistant weeds in sugar beet, in other crops, and in the
    environment?
    Which are the most likely weeds, if any, to gain glyphosate
    resistance
    and why would they gain such resistance with the use of glyphosate-
    tolerant sugar beet? What are the current and potentially effective
    strategies for management of glyphosate-tolerant or other herbicide-
    tolerant weeds in glyphosate-tolerant sugar beet stands or in
    subsequent crops? What are the potential changes that may occur in
    glyphosate-tolerant sugar beet as to susceptibility or tolerance to
    other herbicides?
    Current or prospective herbicide-tolerant weed mitigation
    options.
    What are the potential impacts of current or prospective herbicide-
    tolerant weed mitigation options, including those addressed by the
    EPA-
    approved label for glyphosate herbicides?
    Potential for gene flow from glyphosate-tolerant sugar beet to
    other Beta species, including gene flow between seed fields, root
    crops, and feral plants. To what extent will deregulation change
    hybridization between cultivated and feral sugar beet, sugar beet
    introgression or establishment outside of cultivated lands, and sugar
    beet persistence or weediness in situations where it is unwanted,
    unintended, or unexpected? What are the potential impacts associated
    with feral glyphosate-tolerant sugar beet plants? Will the removal of
    glyphosate-tolerant sugar beet, in situations where it is unwanted,
    unintended, or unexpected, result in adverse impacts? In such
    situations, how will glyphosate-tolerant sugar beet be controlled or
    managed differently from other unwanted, unintended, or unexpected
    sugar beet?
    Economic and social impacts on organic and conventional sugar
    beet,
    Swiss chard, and table beet farmers. What are the economics of
    growing
    organic sugar beet, conventional sugar beet, or glyphosate-tolerant
    sugar beet as well as the economics of growing organic or
    conventional
    Swiss chard and table beet? What are the potential impacts of the
    presence of glyphosate-tolerant sugar beet caused by pollen movement
    or
    seed admixtures? What are the potential impacts of commingling sugar
    beet seed with glyphosate-tolerant sugar beet seed? What are the
    potential changes in the economics of growing and marketing organic
    and
    conventional sugar beet that may occur with the growing of glyphosate-
    tolerant sugar beet? What are the potential changes in production
    levels of other crops that may occur with the growing of glyphosate-
    tolerant sugar beet? Will the cultivation of glyphosate-tolerant
    sugar
    beet result in more or fewer acres of other crops? What are the
    potential changes in growing practices, management practices, and
    crop
    rotational practices in the production of sugar beet seed for
    planting
    purposes that may occur with the use of glyphosate-tolerant sugar
    beet?
    What are the potential changes in the choice of seeds available for
    organic and conventional sugar beet farmers that may occur with the
    use
    of glyphosate-tolerant sugar beet?
    Cumulative impact of potential increased glyphosate usage with
    the
    cultivation of glyphosate-tolerant crops. What are the past, present,
    and future impacts of glyphosate usage on soil quality, water
    quality,
    air quality, weed populations, crop rotations, soil microorganisms,
    diseases, insects, soil fertility, food or feed quality, crop
    acreages,
    and crop yields as a result of the introduction of glyphosate-
    tolerant
    crops? Does the level of glyphosate tolerance within glyphosate-
    tolerant sugar beet plants have an impact on the amount of glyphosate
    applied on the glyphosate-tolerant sugar beet crop on a routine basis?
    Impacts on threatened or endangered species. What are the
    potential
    impacts of glyphosate-tolerant sugar beet cultivation on listed
    threatened or endangered species, or on species proposed for listing?
    What are the potential impacts of glyphosate use on listed threatened
    or endangered species or species proposed for listing, including
    glyphosate used on glyphosate-tolerant sugar beet? What impacts does
    the addition of glyphosate tolerance in sugar beet cultivation have
    on
    threatened and endangered species as a result of displacing other
    herbicides?
    Potential health impacts. What are the potential health impacts
    to
    farmers or others who would be exposed to glyphosate-tolerant sugar
    beet?
    Can any potential negative environmental impacts of the action be
    mitigated and what is the likelihood that such mitigation measures
    will
    be successfully implemented and effective? What is the likely
    effectiveness of the stewardship measures, outlined in the petition,
    which are designed to reduce inadvertent gene flow to negligible
    levels
    as well as to monitor and minimize the potential development of
    glyphosate-tolerant weeds? Are there reasonable alternative
    stewardship
    or monitoring measures that may avoid or minimize reasonably
    foreseeable environmental impacts of a deregulation decision?
    Impacts of the mitigation measures on coexistence with organic
    and
    conventional sugar beet production and on export markets. What are
    the
    potential impacts of mitigation measures on coexistence with organic
    and conventional sugar beet production and on export markets? Are
    there
    reasonable alternative measures that may avoid or minimize reasonably
    foreseeable impacts on organic and conventional sugar beet production
    and on export markets that may be associated with a deregulation
    decision?
    Consideration of reasonable alternatives. The EIS will consider a
    range of reasonable alternatives. These could include continued
    regulation of Roundup Ready[reg] sugar beets, deregulating Roundup
    Ready[reg] sugar beets, deregulating Roundup Ready[reg] sugar beets
    in
    part with geographic restrictions, or deregulating Roundup Ready[reg]
    sugar beets in part with required separation distances from sexually
    compatible crops. Comments that identify other reasonable
    alternatives
    that should be examined in the EIS would be especially helpful.
    Sugar beet growth, crop management, and crop utilization may vary
    considerably by geographic region, and therefore, when providing
    comments on a topic or issue, please provide relevant information on
    the specific locality or region in question. Additionally, we invite
    the participation of any affected Federal, State, or local agencies
    or
    Tribes.
    All comments on this notice will be carefully considered in
    developing the final scope of the EIS. Upon completion of the draft
    EIS, a notice announcing its availability and an invitation to
     
    [[Page 29972]]
     
    comment on it will be published in the Federal Register.
     
    Done in Washington, DC, this 25th day of May 2010.
    Kevin Shea,
    Acting Administrator, Animal and Plant Health

     

    Big Apple <Ernestoman@yahoo.com> May 28 08:00AM -0700 ^
     
    [Federal Register: May 28, 2010 (Volume 75, Number 103)]
    [Notices]
    [Page 30036-30038]
    From the Federal Register Online via GPO Access [wais.access.gpo.gov]
    [DOCID:fr28my10-94]
     
    -----------------------------------------------------------------------
     
    DEPARTMENT OF HEALTH AND HUMAN SERVICES
     
    Food and Drug Administration
     
    [Docket No. FDA-2010-N-0118]
     
     
    Agency Information Collection Activities; Submission for Office
    of Management and Budget Review; Comment Request; Prior Notice of
    Imported Food Under the Public Health Security and Bioterrorism
    Preparedness and Response Act of 2002
     
    AGENCY: Food and Drug Administration, HHS.
     
    ACTION: Notice.
     
    -----------------------------------------------------------------------
     
    SUMMARY: The Food and Drug Administration (FDA) is announcing that a
    proposed collection of information has been submitted to the Office
    of
    Management and Budget (OMB) for review and clearance under the
    Paperwork Reduction Act of 1995.
     
    DATES: Fax written comments on the collection of information by June
    28, 2010.
     
    ADDRESSES: To ensure that comments on the information collection are
    received, OMB recommends that written comments be faxed to the Office
    of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
    FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
    comments should be identified with the OMB control number 0910-0520.
    Also include the FDA docket number found in brackets in the heading
    of
    this document.
     
    FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
    Information Management, Food and Drug Administration, 1350 Piccard
    Dr.,
    PI50-400B, Rockville, MD 20850, 301-796-3793.
     
    SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
    submitted the following proposed collection of information to OMB for
    review and clearance.
     
    Prior Notice of Imported Food Under the Public Health Security and
    Bioterrorism Preparedness and Response Act of 2002--(OMB Control
    Number
    0910-0520)--Extension
     
    The Public Health Security and Bioterrorism Preparedness and
    Response Act of 2002 (the Bioterrorism Act) added section 801(m) of
    the
    Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381(m)),
    which requires that FDA receive prior notice for food, including food
    for animals, that is imported or offered for import into the United
    States. Sections 1.278 through 1.282 of FDA's regulations (21 CFR
    1.278
    through 1.282) set forth the requirements for submitting prior
    notice;
    Sec. Sec. 1.283(d) and 1.285(j) (21 CFR 1.283(d) and 1.285(j)) set
    forth the procedure for requesting FDA review after an article of
    food
    has been refused admission under section 801(m)(1) of the act or
    placed
    under hold under section 801(l) of the act; and Sec. 1.285(i) (21
    CFR
    1.285(i)) sets forth the procedure for post-hold submissions. Advance
    notice of imported food allows FDA, with the support of the U.S.
     
    [[Page 30037]]
     
    Customs and Border Protection (CBP), to target import inspections
    more
    effectively and help protect the nation's food supply against
    terrorist
    acts and other public health emergencies.
    Any person with knowledge of the required information may submit
    prior notice for an article of food. Thus, the respondents to this
    information collection may include importers, owners, ultimate
    consignees, shippers, and carriers.
    FDA's regulations require that prior notice of imported food be
    submitted electronically using CBP's Automated Broker Interface of
    the
    Automated Commercial System (ABI/ACS) (Sec. 1.280(a)(1)) or the FDA
    Prior Notice (PN) System Interface (Form FDA 3540) (Sec. 1.280(a)
    (2)).
    The term ``Form FDA 3540'' refers to the electronic system known as
    the
    FDA PN System Interface, which is available at http://
    www.access.fda.gov. Prior notice must be submitted electronically
    using
    either ABI/ACS or the FDA PN System Interface. Information collected
    by
    FDA in the prior notice submission includes: The submitter and
    transmitter (if different from the submitter); entry type and CBP
    identifier; the article of food, including complete FDA product code;
    the manufacturer, for an article of food no longer in its natural
    state; the grower, if known, for an article of food that is in its
    natural state; the FDA Country of Production; the shipper, except for
    food imported by international mail; the country from which the
    article
    of food is shipped or, if the food is imported by international mail,
    the anticipated date of mailing and country from which the food is
    mailed; the anticipated arrival information or, if the food is
    imported
    by international mail, the U.S. recipient; the importer, owner, and
    ultimate consignee, except for food imported by international mail or
    transshipped through the United States; the carrier and mode of
    transportation, except for food imported by international mail; and
    planned shipment information, except for food imported by
    international
    mail (Sec. 1.281).
    Much of the information collected for prior notice is identical
    to
    the information collected for FDA's importer's entry notice, which
    has
    been approved under OMB control number 0910-0046. The information in
    FDA's importer's entry notice is collected electronically via CBP's
    ABI/ACS at the same time the respondent files an entry for import
    with
    CBP. To avoid double-counting the burden hours are already accounted
    for in the importer's entry notice information collection, and the
    burden hour analysis in table 1 of this document reflects the reduced
    burden for prior notice submitted through ABI/ACS in the column
    labeled
    ``Hours per Response.''
    In addition to submitting a prior notice, a submitter should
    cancel
    a prior notice and must resubmit the information if information
    changes
    after FDA has confirmed a prior notice submission for review (e.g.,
    if
    the identity of the manufacturer changes) (Sec. 1.282). However,
    changes in the estimated quantity, anticipated arrival information,
    or
    planned shipment information do not require resubmission of prior
    notice after FDA has confirmed a prior notice submission for review
    (Sec. 1.282(a)(1)(i) through (a)(1)(iii)). In the event that an
    article of food has been refused admission under section 801(m)(1) or
    placed under hold under section 801(l) of the act, Sec. Sec.
    1.283(d)
    and 1.285(j) set forth the procedure for requesting FDA review and
    the
    information required to be included in a request for review. In the
    event that an article of food has been placed under hold under
    section
    801(l) of the act, Sec. 1.285(i) sets forth the procedure for and
    the
    information to be included in a post-hold submission.
    In accordance with 5 CFR 1320.8(d), in the Federal Register of
    March 16, 2010 (75 FR 12549), FDA published a 60-day notice
    requesting
    public comment on the proposed collection of information. FDA
    received
    one letter, containing multiple comments, in response to this notice.
    These comments were outside the scope of the four collection of
    information topics on which the notice solicits public comment and,
    thus, will not be addressed here.
    FDA estimates the burden of this collection of information as
    follows:
     
    Table 1.--
    Estimated Annual Reporting Burden\1\
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    No.
    of Annual Frequency Total Annual Hours per
    21 CFR Section No. FDA Form No.
    Respondents per Response Responses
    Response Total Hours
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Prior Notice Submissions
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Prior Notice submitted through ABI/ACS
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    1.280 through 1.281 None
    6,500 1,290 8,385,000 0.15
    1,257,750\2\
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Prior Notice submitted through PN System Interface
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    1.280 through 1.281 FDA 3540\3\
    21,500 73 1,569,500
    0.37 580,715
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    New Prior Notice Submissions
    Subtotal
    1,838,465
    --------------------------------------------------------------------------------------------------------------------------------------
    Prior Notice Cancellations
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Prior Notice cancelled through ABI/ACS
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    1.282 FDA 3540
    6,500 3 19,500
    0.25 4,875
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Prior Notice cancelled through PN System Interface
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    1.282 and 1.283(a)(5) FDA 3540
    21,500 3 64,500
    0.25 16,125
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Prior Notice Cancellations
    Subtotal
    21,000
    --------------------------------------------------------------------------------------------------------------------------------------
    Prior Notice Requests for Review and Post-hold Submissions
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    1.283(d) and 1.285(j)
    None 1
    1 1 8 8
    --------------------------------------------------------------------------------------------------------------------------------------------------------
     
    [[Page 30038]]
     
     
    1.285(i)
    None 1
    1 1 1 1
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Prior Notice Requests for Review and Post-hold Submissions
    Subtotal
    9
    --------------------------------------------------------------------------------------------------------------------------------------
    Total Hours
    Annually
    1,859,474
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    \1\ There are no capital costs or operating and maintenance costs
    associated with this collection of information.
    \2\ To avoid double-counting, an estimated 396,416 burden hours
    already accounted for in the Importer's Entry Notice information
    collection approved
    under OMB control number 0910-0046 are not included in this total.
    \3\The term ``Form FDA 3540'' refers to the electronic system known as
    the FDA PN System Interface, which is available at http://www.access.fda.gov.
     
    This estimate is based on FDA's experience and the average number
    of prior notice submissions, cancellations, and requests for review
    received in the past 3 years.
    On November 7, 2008, FDA and CBP issued the prior notice final
    rule
    (73 FR 66294), which finalized the prior notice interim final rule
    (IFR) (68 FR 58894, October 10, 2003). From the IFR to the final
    rule,
    FDA removed a few of the required prior notice data elements.
    Specifically, submitters no longer need to include the fax number of
    the submitter and transmitter, the anticipated border crossing, the
    country of the carrier, or the 6-digit HTS code in their prior
    notices.
    Other changes include the addition of the registration number of the
    transshipper for articles of food for transshipment, storage and
    export, or manipulation and export; flexibility in submitting the
    registration number and the city and country of the manufacturer and
    shipper instead of full addresses of these entities; and the option
    of
    submitting the tracking number for articles of food arriving by
    express
    consignment instead of anticipated arrival information when the prior
    notice is submitted through PN System Interface (73 FR 66294 at
    66402).
    Accordingly, FDA has reduced its estimate of the hours per
    response
    for prior notices received through ABI/ACS from 10 minutes, or 0.167
    hours, per notice, to 9 minutes, or 0.15 hours, per notice. FDA
    received 8,144,419 prior notices through ABI/ACS during 2007;
    8,266,200
    during 2008; and 5,221,549 as of August 26, 2009. Based on this
    experience, FDA estimates that approximately 6,500 users of ABI/ACS
    will submit an average of 1,290 prior notices annually, for a total
    of
    8,385,000 prior notices received annually through ABI/ACS. FDA
    estimates the reporting burden for a prior notice submitted through
    ABI/ACS to be 9 minutes, or 0.15 hours, per notice, for a total
    burden
    of 1,257,750 hours. This estimate takes into consideration the burden
    hours already counted in the information collection approval for
    FDA's
    importer's entry notice, as previously discussed in this document.
    FDA has also reduced its estimate of the hours per response for
    prior notices received through the PN System Interface from 23
    minutes
    to 22 minutes. FDA received 1,744,287 prior notices through the PN
    System Interface during 2007; 1,662,033 during 2008; and 989,708 as
    of
    August 26, 2009. Based on this experience, FDA estimates that
    approximately 21,500 registered users of the PN System Interface will
    submit an average of 73 prior notices annually, for a total of
    1,569,500 prior notices received annually through the PN System
    Interface. FDA estimates the reporting burden for a prior notice
    submitted through the PN System Interface to be 22 minutes, or 0.366
    hours (rounded to 0.37 hours), per notice, for a total burden of
    580,715 hours.
    FDA received 16,215 cancellations of prior notices through ABI/
    ACS
    during 2007; 16,673 during 2008; and 16,045 as of August 26, 2009.
    Based on this experience, FDA estimates that approximately 6,500
    users
    of ABI/ACS will submit an average of 2.64 (rounded to 3)
    cancellations
    annually, for a total of 19,500 cancellations received annually
    through
    ABI/ACS. FDA estimates the reporting burden for a cancellation
    submitted through ABI/ACS to be 15 minutes, or 0.25 hours, per
    cancellation, for a total burden of 4,875 hours.
    FDA received 58,345 cancellations of prior notices through the PN
    System Interface during 2007; 63,779 during 2008; and 55,019 as of
    August 26, 2009. Based on this experience, FDA estimates that
    approximately 21,500 registered users of the PN System Interface will
    submit an average of

     

    Big Apple <Ernestoman@yahoo.com> May 28 07:57AM -0700 ^
     
    [Federal Register: May 28, 2010 (Volume 75, Number 103)]
    [Notices]
    [Page 30033-30035]
    From the Federal Register Online via GPO Access [wais.access.gpo.gov]
    [DOCID:fr28my10-92]
     
    -----------------------------------------------------------------------
     
    DEPARTMENT OF HEALTH AND HUMAN SERVICES
     
    Food and Drug Administration
     
    [Docket No. FDA-2010-N-0119]
     
     
    Agency Information Collection Activities; Submission for Office
    of Management and Budget Review; Comment Request; Registration of
    Food
    Facilities Under the Public Health Security and Bioterrorism
    Preparedness and Response Act of 2002
     
    AGENCY: Food and Drug Administration, HHS.
     
    ACTION: Notice.
     
    -----------------------------------------------------------------------
     
    SUMMARY: The Food and Drug Administration (FDA) is announcing that a
    proposed collection of information has been submitted to the Office
    of
    Management and Budget (OMB) for review and clearance under the
    Paperwork Reduction Act of 1995.
     
    DATES: Fax written comments on the collection of information by June
    28, 2010.
     
    ADDRESSES: To ensure that comments on the information collection are
    received, OMB recommends that written comments be faxed to the Office
    of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
    FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
    comments should be identified with the OMB control number 0910-0502.
    Also include the FDA docket number found in brackets in the heading
    of
    this document.
     
    FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
    Information Management, Food and Drug Administration, 1350 Piccard
    Dr.,
    PI50-400B, Rockville, MD 20850, 301-796-3793.
     
    SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
    submitted the following proposed collection of information to OMB for
    review and clearance.
     
    Registration of Food Facilities Under the Public Health Security and
    Bioterrorism Preparedness and Response Act of 2002-- (OMB Control
    Number 0910-0502)--Extension
     
    The Public Health Security and Bioterrorism Preparedness and
    Response Act of 2002 (the Bioterrorism Act) added section 415 of the
    Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350d),
    which
    requires domestic and foreign facilities that manufacture, process,
    pack, or hold food for human or animal consumption in the United
    States
    to register with FDA. Sections 1.230 through 1.235 of FDA's
    regulations
    (21 CFR 1.230 through 1.235) set forth the procedures for
    registration
    of food facilities. Information provided to FDA under these
    regulations
    will help the agency to notify quickly the facilities that might be
    affected by a deliberate or accidental contamination of the food
    supply.
    Description of Respondents: The respondents to this information
    collection include owners, operators, or agents in charge of domestic
    or foreign facilities that manufacture/process, pack, or hold food
    for
    human or animal consumption in the United States. Domestic facilities
    are required to register whether or not food from the facility enters
    interstate commerce. Foreign facilities that manufacture/process,
    pack,
    or hold food also are required to register unless food from that
    facility undergoes further processing (including packaging) by
    another
    foreign facility before the food is exported to the United States.
    However, if the subsequent foreign facility performs only a minimal
    activity, such as putting on a label, both facilities are required to
    register.
    FDA's regulations require that each facility that manufactures,
    processes, packs, or holds food for human or animal consumption in
    the
    United States register with FDA using Form FDA 3537 (Sec. 1.231).
    The
    term ``Form FDA 3537'' refers to both the paper version of the form
    and
    the electronic system known as the Food Facility Registration Module,
    which is available at http://www.access.fda.gov. The agency strongly
    encourages electronic registration because it is faster and more
    convenient. The system the agency has developed can accept electronic
    registrations from anywhere in the world 24 hours a day, 7 days a
    week.
    A registering facility will receive confirmation of electronic
    registration and its registration number instantaneously once all the
    required fields on the registration screen are filled in. However,
    paper registrations will be accepted. Form FDA 3537 is available for
    download for registration by mail, fax, or CD-ROM. Registration by
    mail
    may take several weeks to several months, depending on the speed of
    the
    mail system and the number of paper registrations that FDA will have
    to
    enter manually.
    Information FDA requires on the registration form includes the
    name
    and full address of the facility; emergency contact information; all
    trade names the facility uses; applicable food product categories
    identified in Sec. 170.3 (21 CFR 170.3), unless ``most/all'' human
    food categories ``or none of the above mandatory categories'' is
    selected as a response; and a certification statement that includes
    the
    name of the individual authorized to submit the registration form.
    Additionally, facilities are encouraged to submit their preferred
    mailing address; type of activity conducted at the facility; food
    categories not included under Sec. 170.3, but which are helpful to
    FDA
    for responding to an incident; type of storage, if the facility is
    primarily a holding facility; and approximate dates of operation if
    the
    facility's business is seasonal.
    In addition to registering, a facility is required to submit
    timely
    updates within 60 days of a change to any required information on its
    registration form, using Form FDA 3537 (Sec. 1.234), and to cancel
    its
    registration when the facility ceases to operate or is sold to new
    owners or ceases to manufacture/process, pack, or hold food for
    consumption in the United States, using Form FDA 3537a (Sec. 1.235).
    In the Federal Register of March 16, 2010 (75 FR 12547), FDA
    published a 60-day notice requesting public comment on the proposed
    collection of
     
    [[Page 30034]]
     
    information. FDA received one letter, containing multiple comments,
    in
    response to the notice.
    (Comment 1) One comment contended that it was unnecessary for
    companies to have to register their facilities with FDA.
    (Response) FDA disagrees. In the Preliminary Regulatory Impact
    Analysis (PRIA) for the proposed rule (see the Federal Register of
    Feburary 3, 2003 (68 FR 5378 at 5387 to 5413)), FDA asserted that
    requiring registration of manufacturers/ processors, packers, and
    holders of food would aid in deterring and limiting the effects of
    foodborne outbreaks in four ways. One, by requiring registration,
    persons who might intentionally contaminate the food supply would be
    deterred from entering the food production chain. Two, if FDA is
    aware
    of a specific food threat, a registration database would make FDA
    better able to inform the facilities potentially affected by the
    threat. Three, FDA would be able to deploy more efficiently its
    domestic compliance and regulatory resources. Four, FDA inspectors,
    using prior notice and registration, would be better able to identify
    shipments offered for import for inspection.
    Registering with FDA creates a paper trail, which would, even if
    the information in the registration were falsified, provide evidence
    that could link the registration to the false registrant. Persons who
    might attempt to intentionally contaminate the U.S. food supply would
    be deterred, by the creation of additional evidence that might be
    used
    against them, from starting a business in the food supply chain.
    Persons who might intentionally contaminate the food supply but
    refuse
    to register would be subject to criminal and civil sanctions and, if
    foreign, would risk having their product held at a U.S. port. With
    emergency contact information and product categories, FDA can quickly
    call or e-mail the emergency contact at both domestic and foreign
    facilities that may be targeted by a specific food threat. If FDA
    suspects a particular product is at risk, the agency can quickly
    identify which facilities to contact. This rapid communication
    ability
    will allow facilities to respond quickly to a threat and possibly
    limit
    the effect of a deliberate strike on the food supply, as well as
    public
    health emergencies due to accidental contamination of food.
    (Comment 2) One comment stated that facilities that hold food
    should not be required to register.
    (Response) FDA disagrees with the suggested change to its
    regulations. The agency's regulations implement the food facility
    registration requirements in section 305 of the Bioterrorism Act,
    which
    requires domestic and foreign facilities that manufacture, process,
    pack, or hold food for human or animal consumption in the United
    States
    to register with FDA.
    (Comment 3) One comment stated that, to lessen the burden of the
    regulation, FDA should not require firms to update their registration
    information, but only to cancel their registration when the facility
    stops holding food.
    (Response) FDA disagrees with the suggested change to its
    regulations. Requiring registrants to update the registration
    information for their facilities will directly enhance FDA's ability
    to
    satisfy the agency's obligation to maintain an up-to-date list of
    registered facilities, as required by section 415(a)(4) of the act.
    FDA
    has balanced the greater efficiency of the agency's having specific
    information regarding food manufactured/processed, packed, or held at
    each facility against the burden on facilities to submit initially
    and
    update this information as circumstances change. Without updated
    emergency contact information and product categories, the agency's
    ability to quickly call or e-mail the emergency contact at facilities
    that may be targeted by a specific food threat would be negatively
    impacted.
    FDA estimates the burden of this collection of information as
    follows:
     
    Table 1.--
    Estimated Annual Reporting Burden\1\
    --------------------------------------------------------------------------------------------------------------------------------------------------------

    Annual Frequency Total Annual Hours per
    21 CFR Section FDA Form No. No. of
    Respondents per Response Responses
    Response Total Hours
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    New Facilities
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Domestic
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    1.230-1.233 FDA 3537\2\
    13,560 1 13,560
    2.5 33,900
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Foreign
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    1.230-1.233 FDA 3537
    23,370 1 23,370
    8.5 198,645
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    New Facility Registration
    Subtotal
    232,545
    --------------------------------------------------------------------------------------------------------------------------------------
    Previously Registered Facilities-Updates (Form 3537) and Cancellations
    (Form 3537a)
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    1.234 FDA 3537
    118,530 1 118,530
    1 118,530
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    1.235 FDA 3537a
    6,390 1 6,390
    1 6,390
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Updates or Cancellations to Existing Registration
    Subtotal
    124,920
    --------------------------------------------------------------------------------------------------------------------------------------
    Total Hours
    Annually
    357,465
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    \1\ There are no capital costs or operating and maintenance costs
    associated with this collection of information.
    \2\ The term ``Form FDA 3537'' refers to both the paper version of the
    form and the electronic system known as the Food Facility Registration
    Module,
    which is available at http://www.access.fda.gov.
     
    This estimate is based on FDA's experience and the average number
    of new facility registrations, updates and cancellations received in
    the past 3 years. FDA received 12,681 new domestic facility
    registrations during 2006; 14,629 during 2007; and 13,378 during
    2008.
    Based on this experience, FDA estimates the annual number of new
    domestic facility registrations will be 13,560. FDA estimates that
    listing the information required by the
     
    [[Page 30035]]
     
    Bioterrorism Act and presenting it in a format that will meet the
    agency's registration regulations will require a burden of
    approximately 2.5 hours per average domestic facility registration.
    The
    average domestic facility burden hour estimate of 2.5 hours takes
    into
    account that some respondents completing the registration may not
    have
    readily available Internet access. Thus, the total annual burden for
    new domestic facility registrations is estimated to be 33,900 hours
    (13,560 x 2.5 hours).
    FDA received 25,513 new foreign facility registrations during
    2006;
    23,302 during 2007; and 21,281 during 2008. Based on this experience,
    FDA estimates the annual number of new foreign facility registrations
    will be 23,370. FDA estimates that listing the information required
    by
    the Bioterrorism Act and presenting it in a format that will meet the
    agency's registration regulations will require a burden of
    approximately 8.5 hours per average foreign facility registration.
    The
    average foreign facility burden hour estimate of 8.5 hours includes
    an
    estimate of the additional burden on a foreign facility to obtain a
    U.S. agent, and takes into account that for some foreign facilities
    the
    respondent completing the registration may not be fluent in English
    and/or not have readily available Internet access. Thus, the total
    annual burden for new foreign facility registrations is estimated to
    be
    198,645 hours (23,370 x 8.5 hours).
    FDA received 114,199 updates to facility registrations during
    2006;
    128,070 during 2007; and 113,318 during 2008. Based on this
    experience,
    FDA estimates that it will receive 118,530 updates annually. FDA also
    estimates that updating a registration will, on average, require a
    burden of approximately 1 hour, taking into account fluency in
    English
    and Internet access. Thus, the total annual burden for updating all
    registrations is estimated to be 118,530 hours.
    FDA received 5,703 cancellations of facility registrations during
    2006; 5,578 during 2007; and

     

    Big Apple <Ernestoman@yahoo.com> May 28 07:53AM -0700 ^
     
    [Federal Register: May 28, 2010 (Volume 75, Number 103)]
    [Notices]
    [Page 29967-29969]
    From the Federal Register Online via GPO Access [wais.access.gpo.gov]
    [DOCID:fr28my10-25]
     
    ========================================================================
    Notices
    Federal Register
    ________________________________________________________________________
     
    This section of the FEDERAL REGISTER contains documents other than
    rules
    or proposed rules that are applicable to the public. Notices of
    hearings
    and investigations, committee meetings, agency decisions and rulings,
    delegations of authority, filing of petitions and applications and
    agency
    statements of organization and functions are examples of documents
    appearing in this section.
     
    ========================================================================
     
     
     
    [[Page 29967]]
     
     
     
    DEPARTMENT OF AGRICULTURE
     
    Agricultural Marketing Service
     
    [Doc. No. AMS-NOP-10-0046; NOP-10-02]
     
     
    National Organic Program Request for an Extension of a Currently
    Approved Information Collection
     
    AGENCY: Agricultural Marketing Service, USDA.
     
    ACTION: Notice and request for comments.
     
    -----------------------------------------------------------------------
     
    SUMMARY: In accordance with the Paperwork Reduction Act of 1995 (44
    U.S.C. Chapter 35), this notice announces the Agricultural Marketing
    Service's intention to request approval from the Office of Management
    and Budget, for an extension of the currently approved information
    collection National Organic Program (NOP) Record Keeping Requirements.
     
    DATES: Comments received by July 27, 2010 will be considered.
     
    ADDRESSES: Interested persons are invited to submit written comments
    concerning this notice. Comments must be sent to Toni Strother,
    Agricultural Marketing Specialist, National Organic Program, AMS/
    USDA,
    1400 Independence Ave., SW., Room 2646-So., Ag Stop 0268, Washington,
    DC 20250-0268 or by Internet: http://www.regulations.gov. Written
    comments responding to this notice should be identified with the
    document number AMS-NOP-10-0046; NOP-10-02. It is USDA's intention to
    have all comments concerning this notice, including names and
    addresses
    when provided, regardless of submission procedure used, available for
    viewing on the Regulations.gov (http://www.regulation.gov) Internet
    site. Comments submitted in response to this notice will also be
    available for viewing in person at USDA-AMS, National Organic
    Program,
    Room 2624-South Building, 1400 Independence Ave., SW., Washington,
    DC,
    from 9 a.m. to 12 noon and from 1 p.m. to 4 p.m., Monday through
    Friday
    (except official Federal holidays). Persons wanting to visit the USDA
    South Building to view comments received in response to this notice
    are
    requested to make an appointment in advance by calling (202) 720-3252.
     
    FOR FURTHER INFORMATION CONTACT: Toni Strother, Agricultural
    Marketing
    Specialist, Standards Division, Telephone: (202) 720-3252.
     
    SUPPLEMENTARY INFORMATION:
    Title: National Organic Program.
    OMB Number: 0581-0191.
    Expiration Date of Approval: October 31, 2010.
    Type of Request: Extension of a currently approved information
    collection.
    Abstract: The Organic Foods Production Act of 1990 (OFPA) as
    amended (7 U.S.C. 6501-6522) mandates that the Secretary develop a
    NOP
    to accredit eligible State program's governing State officials or
    private persons as certifying agents who would certify producers or
    handlers of agricultural products that have been produced using
    organic
    methods as provided for in OFPA. This regulation: (1) Established
    national standards governing the marketing of certain agricultural
    products as organically produced products; (2) assures consumers that
    organically produced products meet a consistent standard; and (3)
    facilitates interstate commerce in fresh and processed food that is
    organically produced.
    Reporting and recordkeeping are essential to the integrity of the
    organic certification system. They create a paper trail that is a
    critical element in carrying out the mandate of OFPA and NOP. They
    serve the AMS mission, program objectives, and management needs by
    providing information on the efficiency and effectiveness of the
    program. The information affects decisions because it is the basis
    for
    evaluating compliance with OFPA and NOP, for administering the
    program,
    for management decisions and planning, and for establishing the cost
    of
    the program. It supports administrative and regulatory actions in
    response to noncompliance with OFPA and NOP.
    In general, the information collected is used by USDA, State
    program governing State officials, and certifying agents. It is
    created
    and submitted by State and foreign program officials, peer review
    panel
    members, accredited certifying agents, organic inspectors, certified
    organic producers and handlers, those seeking accreditation or
    certification, and parties interested in changing the National List.
    Additionally, it necessitates that all of these entities have
    procedures and space for recordkeeping.
    USDA. USDA is the accrediting authority. USDA accredits domestic
    and foreign certifying agents who certify domestic and foreign
    organic
    producers and handlers, using information from the agents documenting
    their business operations and program expertise. USDA also permits
    States to establish their own organic certification programs after
    the
    programs are approved by the Secretary, using information from the
    States documenting their ability to operate such programs and showing
    that such programs meet the requirements of OFPA and NOP.
    States. States may operate their own organic certification
    programs. State officials obtain the Secretary's approval of their
    programs by submitting information to USDA documenting their ability
    to
    operate such programs and showing that such programs meet the
    requirements of OFPA and NOP. The Secretary, or delegated
    representative, will review a State organic program not less than
    once
    during each 5-year period following the date of the initial program
    approval. To date, one State organic certification program is
    approved
    by USDA. The initial burden for each State organic certification
    program is an average of 40 hours or if calculated at a rate of $32
    per
    hour (rounded up to the next dollar) $1,280. State organic
    certification programs require reporting and recordkeeping burdens
    similar to those required by the NOP. The average annual burden for
    States are 55 hours or if calculated at a rate of $32 per hour
    (rounded
    up to the next dollar) $1,760.
    Certifying agents. Certifying agents are State, private, or
    foreign
    entities who are accredited by USDA to certify domestic and foreign
    producers and handlers as organic in accordance with OFPA and NOP.
    Each
    entity wanting to be an agent seeks accreditation from USDA,
    submitting
    information documenting its business operations and program
    expertise.
    Accredited agents determine if a producer or handler meets organic
     
    [[Page 29968]]
     
    requirements, using detailed information from the operation
    documenting
    its specific practices and on-site inspection reports from organic
    inspectors. Initial estimates were based on 59 entities applying for
    accreditation (13 State certifiers, 36 private entities, 10 foreign
    entities). The initial burden for each State certifier was an average
    of 695 hours or if calculated at a rate of $27 per hour (rounded up
    to
    the next dollar) $18,765. The initial burden for each private or
    foreign entity was 700 hours or if calculated at a rate of $27 per
    hour
    (rounded up to the next dollar) $18,900. Currently, 97 certifying
    agents (21 State certifiers, 33 private entities, 43 foreign
    entities)
    have been accredited. The AMS anticipates receiving approximately 3
    new
    applications per year. Accredited certifying agents submit annual
    updates with an annual burden, for each certifying agent, of an
    average
    of 11 hours or if calculated at a rate of $32 per hour (rounded up to
    the next dollar) $352.
    Administrative costs for reporting, disclosure of information,
    and
    recordkeeping vary among certifying agents. Factors affecting costs
    include the number and size of clients, the categories of
    certification
    provided, and the type of systems maintained.
    When an entity applies for accreditation as a certifying agent,
    it
    must provide a copy of its procedures for complying with
    recordkeeping
    requirements (Sec. 205.504(b)(3)). Once certified, agents have to
    make
    their records available for inspection and copying by authorized
    representatives of the Secretary (Sec. 205.501(a)(9)). The USDA
    charges certifying agents for the time required to do these document
    reviews. Audits require less time when the documents are well
    organized
    and centrally located.
    Recordkeeping requirements for certifying agents are divided into
    three categories of records with varying retention periods: (1)
    Records
    created by certifying agents regarding applicants for certification
    and
    certified operations, maintain 10 years, consistent with OFPA's
    requirement for maintaining all records concerning activities of
    certifying agents; (2) records obtained from applicants for
    certification and certified operations, maintain 5 years, the same as
    OFPA's requirement for the retention of records by certified
    operations; and (3) records created or received by certifying agents
    regarding accreditation, maintain 5 years, consistent with OFPA's
    requirement for renewal of agent's accreditation (Sec. 205.5 10(b)).
    Organic inspectors. Inspectors, on behalf of certifying agents,
    conduct on-site inspections of certified operations and operations
    applying for certification. They determine whether or not
    certification
    should continue or be granted and report their findings to the
    certifying agent. Inspectors are the agents themselves, employees of
    the agents, or individual contractors. We estimate that about half
    are
    certifying agents or their employees and half are individual
    contractors. Individuals who apply for positions as inspectors submit
    to the agents information documenting their qualifications to conduct
    such inspections. Estimates: 293 inspectors (147 certifying agents
    and
    their employees, 146 individual contractors). The annual burden for
    each inspector is an average of 1 hour or if calculated at $32 per
    hour
    (rounded up to the next dollar) $32.
    Producers and handlers. Producers and handlers, domestic and
    foreign, apply to certifying agents for organic certification, submit
    detailed information documenting their specific practices, provide
    annual updates to continue their certification, and report changes in
    their practices. Producers include farmers, livestock and poultry
    producers, and wild crop harvesters. Handlers include those who
    transport or transform food and include millers, bulk distributors,
    food manufacturers, processors, repackagers, or packers. Some
    handlers
    are part of a retail operation that processes organic products in a
    location other than the premises of the retail outlet.
    The OFPA requires certified operators to maintain their records
    for
    5 years. We estimate: 36,147 total operators (31,000 certified and
    5,147 exempt), including 27,102 producers (22,128 certified and 4,974
    exempt) and 8,705 handlers (8,532 certified and 173 exempt). The
    annual
    recordkeeping burden for each certified operator is an average of 5
    hours or if calculated at $32 per hour (rounded up to the next
    dollar)
    $160.
    Administrative costs for reporting and recordkeeping vary among
    certified operators. Factors affecting costs include the type and
    size
    of operation, and the type of systems maintained.
    Research studies have indicated that operations using product
    labels containing the term ``organic'' handle an average of 20 labels
    annually and that there are about 8,532 handlers with the term
    organic
    on their label. An estimate of the time needed to develop labels for
    products sold, labeled, or represented as ``100 percent organic,''
    ``organic,'' ``made with organic (specified ingredients),'' or which
    use the term organic to modify an ingredient in the ingredients
    statement is included. Also included is the time spent deciding about
    use of the USDA seal, a State emblem, or the seal, logo, or other
    identifying marks of a private certifying agent (Sec. Sec. 205.300-
    205.310). Because the labeling requirements are in addition to Food
    and
    Drug Administration and Food Safety and Inspection Service
    requirements, the burden measurement does not include the hours
    necessary to develop the entire label. For purposes of calculating
    the
    burden, it is estimated that each handler develops 20 labels
    annually.
    Estimates: 8,532 certified handlers. The annual burden for each
    certified handler is an average of 1 hour per product label times 20
    product labels per handler or if calculated at a rate of $32 per hour
    (rounded up to the next dollar) $640.
    Interested parties. Any interested party may petition the
    National
    Organic Standards Board (NOSB) for the purpose of having a substance
    evaluated for recommendation to the Secretary for inclusion on or
    deletion from the National List. Estimates: 25 interested parties may
    petition the NOSB. The annual burden for each interested party is an
    average of 104 hours or if calculated at $32 per hour (rounded up to
    the next dollar) $3,328.
    Estimate of Burden: Public reporting burden for this collection
    of
    information is estimated to average 1.303 hours per response.
    Respondents: Producers, handlers, certifying agents, inspectors
    and
    State, Local or Tribal governments and interested parties.
    Estimated Number of Respondents: 32,600.
    Estimated Number of Responses: 776,407.
    Estimated Number of Responses per Respondent: 23.8.
    Estimated Total Annual Burden on Respondents: 1,011,647.
    Comments are invited on: (1) Whether the proposed collection of
    information is necessary for the proper performance of the functions
    of
    the agency, including whether the information will have practical
    utility; (2) the accuracy of the agency's estimate of the burden of
    the
    proposed collection of information including the validity of the
    methodology and assumptions used; (3) ways to enhance the quality,
    utility, and clarity of the information to be collected; and (4) ways
    to minimize the burden of the collection of information on those who
    are to respond, including the use of appropriate automated,
    electronic,
    mechanical, or other technological collection techniques or other
    forms
    of information technology.
    All responses to this notice will be summarized and included in
    the
    request
     
    [[Page 29969]]
     
    for OMB approval. All comments will become a matter of public record.
     
    Authority: 7 U.S.C. 6501-6522.
     
    Dated: May 24, 2010.
    Rayne Pegg,
    Administrator, Agricultural Marketing Service.
    [FR Doc. 2010-12833 Filed 5-27-10; 8:45 am]
    BILLING CODE P

     

    Luis <padilla.luis2@gmail.com> May 27 04:38PM -0700 ^
     
    {Not only fear. It looks like that an under-reported story of this
    recession is that portion of the US population may stay on the
    austerity plan for the foreseable future. After getting badly burned
    for taking undue advantage of price deflation, Walmart seems to
    realize this and looks poised to do some "serious" price cutting. A
    possible indication is that the range of the price gap between brand
    names and their private labels is reaching a lower (high-low) range at
    the same time that is shrinking. That's change we can believe in... }
     
     
    The retailers' dilemma
    May 27th 2010
    The Economist
    http://www.economist.com/business-finance/PrinterFriendly.cfm?story_id=16216502
     
    As they decide how to stock their shelves later this year, America's
    shopkeepers are debating whether the recent rise in consumer spending
    will last
     
    THE mood of executives at retail firms normally moves in lockstep with
    that of their customers. But in America the news on May 25th that
    consumer confidence had reached its highest level in two years left
    them oddly subdued. Consumer spending per person, which fell for two
    years in a row for the first time since the Depression last year and
    the year before, has been rising again in recent months. But as retail
    executives place orders for the crucial end-of-year rush, they are
    anxiously debating how strong and lasting the consumer's revival will
    be.
     
    In the first quarter both fancier retailers such as Gap, Macy's and
    Saks and workaday ones like Target, Wal-Mart and Home Depot all
    announced improved results. The rebound has been strongest in luxury
    stores: same-store sales at Neiman Marcus, for example, were 11%
    higher this April than last. But there was also reason for cheer at
    Home Depot, which relies on humbler consumers and the still-low
    housing market: revenues were up by 4.3% on the first quarter of 2009.
    Sales of home-improvement gear such as paint and gardening tools were
    especially strong.
     
    Although profits were up at Wal-Mart, sales at its American stores
    fell by 1.4% compared with a year earlier. "More than ever, our
    customers are living pay cheque to pay cheque," says Tom Schoewe, its
    chief financial officer. "I'm worried," admits the boss of another
    large retail chain, privately. "Things seem a little rougher now than
    in the first quarter." The effect of the government stimulus is
    running out and consumers' finances remain stretched, he confides. The
    International Council of Shopping Centres, a trade group, recently
    trimmed its sales projections for May.
     
    Everyone agrees that American consumers are more cheerful than they
    were last year. A new survey by Deloitte, a consultancy, found that
    nearly two-thirds of them say their financial situation is as good as
    or better than it was a year ago, and that accordingly they plan to
    spend the same as last year or more. "Retailers should be encouraged
    by consumers' tone as they plan for the critical fall and winter
    selling seasons," says Stacy Janiak, who heads Deloitte's retail
    practice in America.
     
    Yet the recent improvement is from a very low base, especially at the
    grandest stores. Neiman Marcus's strong April marked a rebound from a
    22.5% decline in the year to April 2009; the 3.2% increase in revenues
    reported by Saks in the first quarter followed a 32% decline in the
    same period a year earlier, points out Steven Dennis, an analyst at
    Gerson Lehrman, a research firm.
     
    The typical customer "still has a lot of fear in her heart, and she is
    still being very cautious," says Michael Silverstein, a consultant and
    co-author of "Women Want More", which argues that women control the
    lion's share of household spending. "She had over-consumed before the
    recession. At the bottom of the recession, she had nothing unworn,
    nothing new. This spring, she looked at her closet, her kitchen, said,
    'Goddamit, I still have a job', and decided to loosen the purse
    strings."
     
    This might explain the recent sharp increase in spending on lingerie,
    dresses, coats and even the higher sales at Home Depot, given that
    women, Mr Silverstein argues with dogged consistency, tend to initiate
    redecorating sprees. Loosening the purse strings did not mean
    abandoning the frugality that was the clearest consumer trend during
    the recession. "She still bought everything on sale," says Mr
    Silverstein. Moreover, the volatile economy is clearly taking its
    toll; falls in the stockmarket are quickly showing up in lower sales.
    In short, says Mr Silverstein, "It is going to be a stressful summer
    for the consumer. She will be moody."
     
    "The assumption that when the recession was over consumers would
    return to where they were has already been disproved," says Paul
    Leinwand, a consultant at Booz & Company. Retailers are investing
    heavily to track consumers' behaviour in an attempt to work out what
    they might want to buy and how much they are willing to pay.
     
    In general, retailers have learned to focus far more on lowering
    prices, and in particular to stock a larger proportion of products at
    the low end of the price range. Saks has been especially astute at
    this, not least by increasing significantly the share of goods on its
    shelves that carry its own label. This has been a trend across the
    retail industry in the past two years, and no one expects it to be
    reversed now that consumer sentiment is starting to improve. On the
    contrary, the proportion of private-label sales may well continue to
    rise to levels long seen in Europe.
     
    Nor does anyone expect any reversal of another trend: consumers have
    been buying through a growing number of channels, from department
    stores to discount warehouses to the internet, often going online
    first to hunt for the best prices. All of the leading retailers have
    tried to spruce up their online act during the downturn, but few have
    done as well as start-ups such as Gilt Groupe, which uses social
    networking to carry out discounted sales of designer-label clothes and
    homeware, and luxury holidays.
     
    Retailers have also tried to shorten the ordering cycle, so that
    manufacturers end up carrying more of the risk of managing stock. Many
    are trying to replace the standard four annual "seasonal" orders with
    as many as 16 orders a year, says Mr Leinwand. Five years ago only
    Zara, a Spanish clothes retailer, followed such a strategy, but firms
    such as J.C. Penney, Saks and Macy's have since adopted it too.
     
    In some respects, it was easier for retailers to plan during the
    recession, provided they had accepted the gruesome reality, since
    plunging sales were all but assured. Now, there is great uncertainty
    about what consumers will do. If the recent uptick in sales proves
    short-lived, retailers who extrapolate from the latest numbers will
    spend a miserable holiday season trying to offload unwanted stock at
    crippling discounts. Conversely, excessive pessimism could lead to
    empty shelves, disappointed customers and red faces in the executive
    suite. "I am trying to create the flexibility in our supply chain to
    deal with both these scenarios," says the worried boss of the large
    retail chain. He, unlike the typical consumer, is finding little
    comfort in retail therapy.

     

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