Fw: (Fresh Produce) Digest for freshproduce@googlegroups.com - 13 Messages in 9 Topics
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Date: Fri, 28 May 2010 21:34:01 +0000
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Subject: (Fresh Produce) Digest for freshproduce@googlegroups.com - 13 Messages in 9 Topics
Group: http://groups.google.com/group/freshproduce/topics
- Wooden pallets tests revealed the presence of bacteria that cause food poisoning including E. coli and Listeria. FDA regs requested. [3 Updates]
- Fresh Produce Discussion Blog : Restaurant Industry Outlook Remained Positive... [2 Updates]
- University, Massachusetts company to launch training center for foreign producers. [2 Updates]
- Fresh Produce Discussion Blog : Canadians are eating more fruits and vegetables [1 Update]
- ACTION: Notice of intent to prepare an environmental impact statement. Determination of Nonregulated Status of Sugar Beet Genetically Engineered [1 Update]
- ACTION: Notice. Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act [1 Update]
- ACTION: Notice. Comment Request; Registration of Food Facilities [1 Update]
- ACTION: Notice and request for comments. National Organic Program Request for an Extension [1 Update]
- The retailers' dilemma [1 Update]
- 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
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- 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
- Tom Karst <tkarst@thepacker.com> May 28 08:36AM -0700 ^
Tom Karst has sent you a link to a blog:
he total daily intake of calories per person fell to 2,357.8 in 2009,
down 155.6 calories from 2001.
Blog: Fresh Produce Discussion Blog
Post: Canadians are eating more fruits and vegetables
Link:
http://freshproducetalk.blogspot.com/2010/05/canadians-are-eating-more-fruits-and.html
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- 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
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
Topic: The retailers' dilemma
- 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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posted by Tom Karst @ 4:53 AM
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