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April 19, 2012 -
FDA rule addresses
residue tolerance levels
The 90-day public comment period on a
U.S. Food and Drug Administration (FDA) proposed rule involving
the presence of banned animal drugs on imported food ends on
The rule would establish a framework
for setting a tolerance level for residues of animal drugs that
have not been approved for use in the United States. The FDA
commissioner would be allowed to set a tolerance level if the
manufacturer sufficiently proves that the drug is safe at a
particular level. Essentially, the rule establishes methods for
submitting, amending or revoking an import tolerance
Currently, the FDA has a zero
tolerance policy for residues of unapproved animal drugs on
imported food. Many U.S. seafood importers support the rule, the
final step in the process of fully implementing the Animal Drug
Availability Act of 1996. Imported seafood can be detained at
the port of entry and barred from entering the marketplace for
containing trace amounts — often measures in parts per billion —
of an unapproved animal drug.
However, the Catfish Farmers of
America (CFA) is among those opposing the rule because it says
the rule could compromise the safety of the U.S. food supply.
“U.S. consumers deserve to know that
their fish is safe,” said CFA President Butch Wilson. “This
proposed rule would create a loophole where potentially
dangerous and banned drugs, reach American dinner tables. If a
drug hasn’t been approved for use here in the United States, it
should not be allowed in imports. We strongly urge the Obama
administration to reconsider this ill-advised rule.
“It is concerning that the
administration is moving toward allowing unapproved drugs to be
used in imported food while those same drugs are banned for use
here in the United States — it is a double standard,” added
April 16, 2012
- NAA Industry Update
The US Food
and Drug Administration (FDA) announced on March 9, 2012 a major
effort to help reduce the prevalence of human and animal
pathogens resistant to antimicrobial drugs. FDA is taking three
steps to protect public health and promote the judicious use of
medically important antibiotics in food-producing animals,
including farmed fish.
issued a final guidance for industry “The Judicious Use of
Medically Important Antimicrobial Drugs in Food-Producing
Animals” (Guidance Document #209). This guidance recommends
phasing out the use of antimicrobial drugs for growth
promotion and phasing in veterinary oversight of
issued a draft guidance (Guidance Document #213) that will
assist drug companies to voluntarily remove “production”
uses and change over-the-counter (OTC) drugs, such as
Terramycin® drugs to a Veterinary Feed Directive drug (VFD).
proposed a Veterinary Feed Directive regulation that is open
for public comment.
primarily directed at terrestrial animal uses in which some
antimicrobial drugs are used for growth promotion, the FDA
action applies to all antimicrobial drugs administered via feed
including those used to treat diseased fish. In the US there
are three antimicrobial drugs currently approved by FDA and
available: Terramycin® (oxytetracycline), Romet-30® (sulfadimethoxine/ormetoprim),
and Aquaflor® (florfenicol). Only Aquaflor® is a VFD drug. The
drug sponsors of Terramycin and Romet-30 are being encouraged by
the FDA to change their OTC status to the VFD status. FDA
expects drug sponsors to complete this conversion within 3
To use a VFD
drug a producer will need to obtain a VFD form signed by their
veterinarian and delivered to a feed mill. The feed mill is
then able to distribute the VFD medicated feed to the producer.
information can be found at:
12, 2012 -
NC Student Fisherman Catches
Record 66 Pound Bass In Mountains
The NC Wildlife Commission, Reprinted By The Raleigh Telegram
MURPHY – When he launched his 17-foot Hydrosport on Hiwassee
Reservoir on the morning of March 31st, Tyler Shields expected
he’d catch a few largemouth bass, maybe a smallmouth bass or
two. What he didn’t expect to catch, however, was the new
freshwater striped bass state record.
Shortly before noon, the 17-year old from Murphy, N.C., reeled
in a massive 66-pound striped bass, using a black zoom trick
worm and 10 pound test on a Bass Pro Shops Bionic Blade rod.
Shields’ state record striped bass eclipses the previous one,
also caught in Hiwassee, by nearly 12 pounds. That fish weighed
54.2 pounds and was caught by Larry Keith Verner, also of
Murphy, on June 6, 1991.
When he first hooked the giant fish, Shields, who was who was
fishing with his cousin, Logan Howard, 15, and friend, Caleb
Davis, 15, thought that it was a catfish. However, when he got
the fish to the boat, he saw that it was “a big striper.” He
didn’t realize how big it was until he got to the dock and a
friend’s father, Brian Kilpatrick, suggested that it might be a
new state record and recommended that Shields get it weighed.
The grocery store that Shields visited initially had scales that
went up to only 50 pounds. He eventually had the fish weighed on
N.C. Department of Agriculture-certified scales at Interstate
Welding and Steel Supply, in Marble.
Powell Wheeler, a district fisheries biologist for the N.C.
Wildlife Resources Commission, verified that the behemoth was a
striped bass and exceeded the existing state record.
Shields, who has a lifetime fishing license, prefers trying his
luck on Hiwassee because of its close proximity to his home and
because he knows Hiwassee so well — not surprising since it’s
the only the lake he’s fished since he picked up a rod and reel
four years ago.
Although he said he knew that the last state record striped bass
came from Hiwassee — and had heard of anglers occasionally
catching whopper striped bass — Shields said he prefers catching
largemouth, smallmouth and spotted bass year round, and catfish
in the summer.
As evidenced by the two state records, Hiwassee Reservoir
harbors some very large striped bass, particularly for reservoir
striped bass, which typically don’t get as large as their
Striped bass, or “stripers,” are regarded mostly as a coastal
water fish, living their adult lives in the ocean and migrating
up into coastal rivers to spawn. If conditions are right, as
they are in Hiwassee, striped bass can thrive in freshwater.
The Wildlife Commission stocks striped bass into several
freshwater reservoirs in the Piedmont and Mountain regions, but
ironically, Hiwassee Reservoir is not stocked with striped bass.
Striped bass in Hiwassee are the “Houdinis” of the fish world,
having traversed several obstacles to make it into the
“We’ve always focused on other fisheries in Lake Hiwassee,
particularly walleye and black basses,” Wheeler said. “However,
the Georgia Department of Natural Resources stocks stripers
upstream of Hiwassee in Nottely Reservoir. Occasionally, a
striper survives passing through Nottely Dam turbine or over the
spillway and swims 13 miles down the Nottely River to Hiwassee
The few striped bass that make it from Nottely Reservoir to
Hiwassee tend to grow very large, very fast.
“The rarity of striped bass in Hiwassee coupled with the
abundance of forage fishes in the reservoir are the main reasons
why Hiwassee has produced the last two freshwater fishing state
records for striped bass,” Wheeler said. “In the middle of
Hiwassee where stripers are often found, there is simply a lot
of food and few other predators to compete with.”
The Wildlife Commission does not manage Hiwassee Reservoir
actively for striped bass, but Wheeler said that he has had
several encounters with large stripers in some of his
“Some anglers also are aware of these very large, but rare,
fish,” Wheeler said. “They’ll actively target them in Hiwassee.”
However, most Hiwassee anglers, like Shields, prefer fishing for
largemouth bass and smallmouth bass.
Shields’ record is unique in that it not only breaks the
freshwater state record, but also exceeds the current saltwater
state record as well. That striper, which was caught off Oregon
Inlet in 2011, weighed 64 pounds, according to the N.C. Division
of Marine Fisheries, which recognizes state records of fish only
from oceans, estuaries and coastal rivers.
To qualify for a N.C. Freshwater Fish State Record, anglers must
have caught the fish by rod and reel or cane pole, have the fish
weighed on a scale certified by the N.C. Department of
Agriculture, witnessed by one observer, have the fish identified
by a fisheries biologist from the Commission, and submit an
application with a full, side-view photo of the fish.
April 10, 2012
- NAA Industry Update
Approval of Two New
The U.S. Food
and Drug Administration announced the approval of Aquaflor (florfenicol)
Type A medicated article and the end of the 5-year marketing
period for the conditionally approved Aquaflor-CA1 (florfenicol)
Type A medicated article. The approval of Aquaflor adds two new
indications, increases the maximum florfenicol dose for a
previously approved indication, and establishes a single
withdrawal period for all approved uses.
warmwater finfish: For the control of mortality due to
streptococcal septicemia associated with Streptococcus
finfish: For the control of mortality due to columnaris
disease associated with Flavobacterium columnare
are associated with significant losses in U.S. aquaculture.
marks the first transition of a conditionally approved
indication to a fully approved product. The conditionally
approved indication for columnaris disease in catfish is a
subset of the columnaris disease indication for
freshwater-reared finfish that is now fully approved.
approval, the maximum florfenicol dose that may be administered
to catfish for the previously approved enteric septicemia of
catfish indication has increased to 15 mg/kg body weight/day
providing a dose range of 10-15 mg/kg body weight/day. With the
increase in the maximum florfenicol dose that may be
administered to catfish and the addition of the new indications,
the withdrawal period for catfish has been lengthened from 12
days to 15 days. Aquaflor now has a single withdrawal period of
15 days for all approved uses.
Aquaflor is a
veterinary feed directive drug, which means that the medicated
feed can only be fed on the order of a licensed veterinarian.
The extra-label use of medicated feed manufactured with Aquaflor
is strictly prohibited. To locate an aquatic veterinarian go to
extensive data to ensure the product met all necessary
effectiveness, target animal safety, human food safety,
environmental safety, and manufacturing standards. FDA has
concluded that freshwater-reared finfish fed florfenicol
according to the label directions are safe for human
available feeds are commonly used to prepare medicated feeds for
use in freshwater-reared finfish species. Consequently, in
current practice, feeds having the same or similar composition
as salmonid or catfish feeds are often used to deliver an
approved new animal drug to non-salmonid and non-catfish
freshwater-reared finfish species while meeting the nutritional
requirements of these finfish species. Because the nutritional
composition of feeds may affect characteristics such as the
mixing, stability, and accuracy of assay of drugs they contain,
an evaluation of these characteristics was performed. The
evaluation of florfenicol for use in freshwater-reared finfish
was performed on catfish and salmonid feeds that varied in some
common nutritional parameters; lipids and protein ranged from 5
to 25% and from 28.5 to 55%, respectively.
of Aquaflor is the result of cooperation between the
pharmaceutical company, Intervet, Inc., and public sector
researchers. The following government groups generated and
contributed data for the approval: U.S. Fish and Wildlife
Service, Aquatic Animal Drug Approval Partnership Program,
Bozeman, MT; U.S. Department of Agriculture, Agricultural
Research Service, Stuttgart National Aquaculture Research
Center, Stuttgart, AR; U.S. Geologic Survey, Upper Midwest
Environmental Sciences Center, La Crosse, WI; Florida Fish and
Wildlife Conservation Commission, Florida Bass Conservation
Center, Webster, FL; Mississippi State University, Thad Cochran
National Warmwater Aquaculture Center, Stoneville, MS; and
Washington Department of Fish and Wildlife, Bellingham State
Fish Hatchery, Bellingham, WA.
Aquaflor is a product of Intervet, Inc., Summit, New Jersey. For
certain indications, Aquaflor is designated under the Minor Use
and Minor Species Animal Health Act of 2004, which entitles
Intervet, Inc. to seven years of exclusive marketing rights for
these indications beginning on the date of approval.
information on Aquaflor go to
30, 2012 -
Lacey Act a
tangle of aquaculture regulation
Gibson guitar clashed with Lacey Act
House Agriculture Committee is set to get an education about
Mid-South agriculture when it holds a farm bill field hearing in
Jonesboro, Ark., on Friday morning.
Freeze will make sure the lawmakers understand the issues that
are important to aquaculture. On Wednesday, Freeze, who operates
a central-Arkansas fish farm, spoke with
about his testimony before the committee, seafood inspections,
the Lacey Act, a safety net for fish farmers, and the FSA office
closings. Among his comments:
issues fish farmers are facing depends on what kind of
aquaculture you’re in: catfish, bait and ornamental fish or some
other type. At our farm, Keo Fish Farm, we raise hybrid striped
bass and triploid grass carp. That means we ship live product
nationally and internationally.
baitfish and ornamental fish farmers, the top priority is the
Lacey Act, which was written in 1900. Unfortunately, it
regulates our domesticated fish as if they were taken out of the
be extremely careful moving live product from one state to
another. A state penalty may be a $50 misdemeanor. However, if
you cross the state line that same $50 state misdemeanor is
elevated to a federal felony under the Lacey Act. The penalties
start at $100,000 and four months in the federal penitentiary.
Lacey Act has been a concern for quite a few years in the
aquaculture industry. In fact, in the last farm bill, the Lacey
Act was amended to include wood and wood products. That’s why
Gibson Guitar got into so much trouble a few months ago because
they’d brought in some exotic wood from India. India said the
wood was legal for export but the U.S. Fish and Wildlife Service
(a bureau in the Department of Interior) interpreted their law
as making it illegal. That incident made a big splash.
on the Gibson incident, see
we deal with that every day with aquaculture products. And one
big problem for farmers is there’s no place to go to find out
what the laws are that we aren’t supposed to violate.
tell the committee about that.”
a move to amend the Lacey Act?
Lacey Act is good for what it was intended to do originally – to
regulate the illegal take of wild game and fish. Of course, when
the act was written in 1900 there was hardly any aquaculture, if
problem we have with the Lacey Act is the definition that says
it pertains to wild animals and fish. Then it goes on to say
‘even those fish that are reared in captivity.’ So, it
specifically includes aquaculture.
was a turkey farmer following all the guidelines and health
inspections of USDA, state laws and the like, I could truck them
across state lines. Nobody would treat my shipment as if it was
made up of wild turkeys.
used to say that you had to ‘knowingly’ break the law for the
Lacey Act to kick in. If you had ignorance of the act it used to
be a defense. You could be charged with the state misdemeanor
but not with the federal felony.”
was changed in the 1990s and U.S. Fish and Wildlife has really
stepped up the use of the Lacey Act.
farmer in Wisconsin forgot to get a free, annual permit from the
state department of agriculture. I don’t think they send out a
renewal notice and he just forgot to get it. Everything else was
legal – disease inspections, all the other permits.
because he didn’t have that permit he was charged under the
Lacey Act. Of course, facing a $100,000 fine, he plea-bargained
down to a $5,000 fine. As part of the plea bargain, though, he
was told, ‘We need to inspect those farm-raised minnows you’re
bringing in from Arkansas – even though (the
Aquaculture/Fisheries Center at the University of Arkansas at
Pine Bluff) is inspecting them and says they’re safe.’
meant the farmer had to send samples of every shipment of
minnows he bought to the U.S. Fish and Wildlife lab in LaCrosse
and pay the bill. Well, that cost the farmer around $78,000. So,
despite the plea-bargain, he was close to the original $100,000
actually asked the
National Agricultural Law Center at the University of
Arkansas to look at the Lacey Act. Elizabeth Rumley, an attorney
there, wrote a report (see
on it and concluded that farm-raised fish should be exempt from
the Lacey Act.
the things that scares us are Senate bills that would expand the
Lacey Act and give them authority over aquatic fish diseases.
The U.S. Fish and Wildlife has some authority over certain trout
diseases. But all the aquatic animal diseases are already
regulated by USDA, APHIS, and veterinary services.
someone does something wrong, they should be held accountable.
However, the punishment has to meet the crime. The Lacey Act is
now so far out of whack that when you tell people about it, they
have a hard time believing it.”
Feb 22, 2012
Hatchery Closure Possible Due to Drought
Parks and Wildlife Department (TPWD) may temporarily close the
Dundee Fish Hatchery near Wichita Falls during the upcoming
production season due to a declining water supply.
have not officially made the decision to suspend operations at
Dundee for 2012, it looks like we will not have water to operate
this spring, and we do not plan to put any ponds into production
unless conditions change within the next couple of weeks,” said
Todd Engeling, hatchery program director for TPWD.
have had restrictions placed on our water use in the past due to
drought conditions, as far as I know this is the first time that
it has resulted in a temporary suspension in operations at any
of our facilities.”
Archer County below Lake Diversion, the Dundee Fish Hatchery has
97 ponds and 84 total acres of water, representing 34 percent of
the state’s available freshwater fish production capacity. It is
the state’s primary producer of striped bass and hybrid striped
bass, turning out 3 million to 4 million fingerlings annually.
constructed in 1927 and renovated in 1994, Dundee receives its
water supply under contract with the Wichita County Water
Improvement District No. 2, which provides water primarily for
irrigation and municipal use. The hatchery gets its water from
Lake Diversion, which is a constant level reservoir fed by Lake
in that part of the state has left water levels in Lake Kemp
very low, resulting in restricted water use,” Engeling said.
“Under the water district’s drought plan, the hatchery is not
allowed to divert water when water elevations in Lake Kemp reach
1125 feet above mean sea level. The water elevation in Kemp is
currently 1126 and is expected to drop to 1125 early this spring
when irrigation activity increases.”
four other freshwater fish hatcheries. They are the
A.E. Wood Fish Hatchery in San Marcos; the Texas Freshwater
Fisheries Center in Athens; the Possum Kingdom Fish Hatchery
near Graford; and the John D. Parker East Texas Fish Hatchery
near Jasper. Water supplies at those hatcheries are not in
immediate danger but could become impacted if the drought
“That is not to
say that operations at the other facilities will not be
impacted,” Engeling said. “Continued production of striped bass
and hybrid striped bass fingerlings is a high priority, because
they support valuable and popular sport fisheries throughout the
state. We may need to adjust normal production plans and shift
efforts at other facilities away from largemouth bass to produce
these fingerlings. Our goal is to balance the priorities and
needs for both species in supporting fisheries management
efforts with available hatchery space.” TPWD typically produces
8 million to 9 million largemouth bass and 4 million to 5
million striped bass and hybrid striped bass fingerlings each
bass populations should be fine with a short-term reduction in
stocking numbers,” said Dave Terre, the fisheries management and
research program director for TPWD.
“Unlike largemouth bass, fisheries for striped and hybrid
striped bass are almost totally supported through our stocking
2012 - NAA Industry Update
this new analysis of the seafood trade deficit and other
products by Joe Myers, Aquaculture Development Specialist,
Office of Aquaculture Coordination, Division of Agricultural &
Natural Resources, New Jersey Department of Agriculture.
trade deficit trend continues upward with clearly bold actions
needed by many that encourage and generate new investments that
result in profitable businesses and companies with new industry
growth in aquaculture and fisheries. See table below for the
deficit at $10.887 billion in 2011.
Fish/shellfish rank in deficit
Fish/shellfish value ($billion)
Largest Food Item Deficit Contributor (00190) Wine and
related products #37 (00190) Wine and related products #31
(00190) Wine and related products #31 (00190) Wine and related
products #23 (00190) Wine and related products #25 (00000)
Green coffee #24
Item Surplus Contributor
(00200) Feedstuff and foodgrains #3 (00200) Feedstuff and
foodgrains #2 (00200) Feedstuff and foodgrains #1
(00200) Feedstuff and foodgrains #2 (00200) Feedstuff and
foodgrains (00200) Feedstuff and foodgrains #1
(10000) Crude (10000) Crude (10000) Crude (10000) Crude
(10000) Crude (10000) Crude
(30000) Passenger cars, new and used (30000) Passenger cars,
new and used (30000) Passenger cars, new and used (40000)
Apparel, household goods - textile (40000) Apparel,
household goods - textile (40000) Apparel, household goods
(22000) Civilian aircraft, complete-all types (22000) Civilian
aircraft, complete-all types (00200) Feedstuff and foodgrains
(22090) Civilian aircraft, engines, equipment, and parts
(00200) Feedstuff and foodgrains (00200) Feedstuff and
deficit grew 14.4% over previous year. Record High remains
and shellfish deficit passes $10.89 billion mark (a 8.2%
increase over 2009)
"China-Effect" readily apparent from trade data. Both imports
from and exports to China increase to hold seafood trade deficit
with China relatively stable.
coffee ($6.905 billion) surpasses (00190) Wine and related
products ($6.767 billion) as #2 trade deficit contributor for
agricultural categories post record surpluses or record
to greater surplus noted in (10010) Fuel oil, (14270)
Nonmonetary gold, (10020) Other petroleum products.
2012 - NAA Industry Update
is hosting a public meeting to share information about the
Agency's budget, process improvement efforts, and modernization
initiatives, and to provide an opportunity for stakeholders to
share their thoughts on partnerships and the Agency's critical
services. The meeting will be held on February 27, 2012, from 1
p.m. to 3 p.m. in the Jefferson Auditorium at the USDA South
Building, 1400 Independence Avenue SW., Washington, DC.
USDA will also
accept stakeholder feedback on the specific topics until March
23, 2012. Those comments should be directed to Ms. Hallie
Zimmers, Stakeholder Liaison, Legislative and Public Affairs,
APHIS, Room 1153, 1400 Independence Avenue SW., Washington, DC
20250; phone (202) 720-0378; or by using the Web form provided
on the APHIS stakeholder information Web site at
http://www.aphis.usda.gov/stakeholders/. Responses may also
be submitted via email to
INFORMATION: The U.S. Department of Agriculture (USDA) is
currently undertaking a variety of efforts to transform itself
into a customer-focused, high-performing organization. In this
context, USDA's Animal and Plant Health Inspection Service
(APHIS) is focusing on ways to share timely information with its
stakeholders and communicate the value APHIS places on our many
and diverse stakeholder relationships.
As part of a
larger effort to enhance stakeholder communication, APHIS is
hosting an open meeting with all interested stakeholders to talk
about the Agency's budget, process improvement efforts, and
modernization initiatives and to provide stakeholders with an
opportunity to share their thoughts on partnerships and the
Agency's critical services. While we welcome comments and
feedback on all aspects of APHIS-stakeholder partnerships and
the Agency's critical services, we are particularly interested
in our stakeholders' thoughts on the topics discussed below.
In this era of
shrinking budgets, Federal Agencies are facing hard choices
about the delivery of important services, and APHIS is no
exception. Some decisions have already been made with respect to
our programs, and we anticipate more difficult choices will be
required in the future. This means that it will be more
important than ever for APHIS to understand its stakeholders'
concerns and priorities.
1. As we take
stock of our current programs and services and consider where,
if necessary, there should be strategic cuts or across-the-board
reductions, we are interested in hearing from stakeholders about
those APHIS activities you most value and where and how you
think the Agency might make responsible changes.
opinion, what are the three to five most essential services
APHIS provides and why?
any feedback regarding how you feel we can best structure or
provide these services.
When you or
your members seek APHIS' assistance, do you primarily rely on
our local field offices, State offices, regional offices,
research centers and field stations, or headquarters for
As we continue
to look at ways to improve our processes and enhance customer
service, what recommendations do you have for specific efforts
we could undertake in 2012?
limited resources, APHIS is seeking new ways to enhance existing
partnerships and build new ones.
How might we
strengthen current partnerships or collaborate in new ways to
accomplish critical mission activities?
Do you see
opportunities for APHIS, State governments, tribes, industry and
academia to redefine traditional roles to find efficiencies or
improvements in the way we collectively safeguard American
agriculture? As best you can, please be specific or provide
provide any additional comments or feedback you would like to
share with APHIS' leadership, especially as it relates to how
you like to see APHIS management communicate with you at the
local, regional, and national level. Please be specific.
registration will begin at noon on the day of the meeting. All
participants must register. If you require special
accommodations, such as a sign language interpreter, or if you
have any questions regarding the meeting, please call or write
Ms. Hallie Zimmers, Stakeholder Liaison, Legislative and Public
Affairs, APHIS, Room 1153, 1400 Independence Avenue SW.,
Washington, DC 20250; phone (202) 720-0378.
If you are
unable to attend the meeting in person, it will be streamed on
the Internet as a live Webcast. To view the Webcast, go to
http://www.aphis.usda.gov/stakeholders/ and follow the
instructions to access the streaming video and audio in ``listen
only'' mode. We recommend you connect at least 5 minutes prior
to the start of the meeting. A recording of the Webcast will be
posted to the APHIS stakeholder information page the following
day, and a written transcript will be posted to the page as soon
as it is available.
attending the February 27, 2012, meeting in Washington, DC, will
be required to sign in at the entrance to the USDA South
Building located at 14th Street and Independence Avenue,
entering through Wing 7. Photo identification is required to
gain access to the building. The nearest Metro station is the
Smithsonian station on the Blue/Orange Lines, which is within
easy walking distance.
2012 - NAA Industry Update
proposing to establish procedures by which a person may request
that the Agency establish or amend tolerances for unapproved new
animal drugs where edible portions of animals imported into the
United States may contain residues of such drugs (import
tolerances), as well as procedures to revoke an existing import
tolerance. This proposed rule has implications for
farmed-raised aquaculture products imported into US seafood
markets. Such import tolerances provide a basis for legally
marketing food of animal origin that is imported into the United
States and contains residues of unapproved new animal drugs.
25, 2012 FDA Federal Register Proposed Rule
on "Import Tolerances
for Residues of Unapproved New Animal Drugs in Food" is posted
for public comments is April 24, 2012.
of the Proposed Rule:
(Proposed Sec. 510.201)
510.201 establishes and restricts proposed subpart C to
procedures by which the Agency may establish, amend, or revoke
an import tolerance for residues of a new animal drug not
approved or conditionally approved for use in the United States
but lawfully used in other countries and present in imported,
animal-derived food and food products, as well as procedures to
reconsider or stay actions regarding an import tolerance. Under
section 512(a)(6) of the FD&C Act, the Secretary may consider
and rely on data submitted to appropriate regulatory authorities
in any country where the new animal drug is lawfully used. In
addition, the Secretary may use data available from a relevant
international organization to the extent such data are not
inconsistent with the criteria used to establish a tolerance for
new animal drug applications submitted under section 512(b)(1)
of the FD&C Act. For purposes of section 512(a)(6) of the FD&C
Act, ``relevant international organization'' means the Codex
Alimentarius Commission or other international organization
deemed appropriate by the Secretary.
evaluating the residue of a new animal drug as part of the
determination of a tolerance, FDA considers the conditions of
use including dose, duration, and formulation. The conditions of
use can affect the uptake, metabolism, and distribution of the
residues in the treated food animal and therefore, are a
critical component of the human food safety evaluation for a
tolerance of a domestic new animal drug as part of a new animal
drug approval. Similarly, the Codex Alimentarius requires that a
veterinary drug under evaluation for an MRL be approved in at
least one member country in order to assure that the conditions
of use are available as part of the scientific evaluation. FDA
believes that it would also be important that the evaluation for
a tolerance for residues of a new animal drug in imported food
consider conditions of use. Consequently, FDA believes that the
new animal drug under evaluation must be lawfully used in at
least one country in a manner consistent with the conditions of
use that cause the residues in the imported food, and that the
information resulting from this lawful use be made available to
FDA as part of the evaluation for an import tolerance.
2012 - NAA Industry Update
Aquaculture Association has developed a narrated PowerPoint
presentation, “U.S. Aquaculture: The New Face of Farming.” which
is now available on the NAA website. The presentation provides
an extensive overview of aquaculture and is designed to be used
with civic groups, school classes, and other local programs.
Run time is approximately 17 minutes.
presentation traces aquaculture back to its historical
beginnings in the civilizations of ancient Egypt, China, and the
Roman Empire. A major focus is the diversity of the industry
from aquatic plants to food fish and shellfish to ornamentals to
baitfish and stockers for the recreational community. It even
delves into future possibilities such as energy generation and
message is that U.S. aquaculture is safe and sustainable. Most
people are unaware of aquaculture. If they do have some
knowledge, it is often filled with misconceptions generated by
the media. This presentation provides contra-arguments for a
more balanced perspective.
During one of
NAA's stakeholder workshops, a local government official
commented that she often hears the negatives about aquaculture
development from environmental groups, but never hears the other
side of the argument and we need to do a better job of
delivering that message. This presentation attempts to provide
that message in a user-friendly way. Many of the producers and
educators who attended NAA-sponsored workshops during the past
two years, requested copies of a PowerPoint to use when asked to
speak at local programs and in classrooms. This presentation is
an effort to use those existing resources and opportunities to
help educate a larger segment of the general public.
The need to
grow the U.S. aquaculture industry to meet the demands of a
growing population that is increasingly focused on leisure
activities and the adoption of a healthier lifestyle is a
message that must be delivered if our industry is to prosper.
Aquaculture: The New Face of Farming" can be viewed at
www.thenaa.net. Copies are also available upon
request to NAA members,
extension agents, educators, culinary professionals, civic
clubs, media, etc. by contacting the NAA at 870.850.7900 or