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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 Tuesday.

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 application.


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 Wilson.


April 16, 2012 - NAA Industry Update 


FDA Announces Move to

Veterinary Feed Directive


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. 

  • ·     FDA 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 therapeutic uses.

  • ·     FDA 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).

  • ·     FDA proposed a Veterinary Feed Directive regulation that is open for public comment.

While 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 years. 


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.


Further information can be found at:


 April 12, 2012 -


NC Student Fisherman Catches Record 66 Pound Bass In Mountains

Photo: NCWRC


By 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 coastal counterparts.


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 reservoir.


“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 Reservoir.”


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 fish-sampling work.


“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



New FDA Approval of Two New

Indications for Aquaflor


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.


The new indications are:

  • ·     Freshwater-reared warmwater finfish: For the control of mortality due to streptococcal septicemia associated with Streptococcus iniae  

  • ·     Freshwater-reared finfish: For the control of mortality due to columnaris disease associated with Flavobacterium columnare

Both diseases are associated with significant losses in U.S. aquaculture.


This approval 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.


With this 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


FDA reviewed 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 consumption.


Commercially 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.


This approval 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.


For more information on Aquaflor go to and


Additional Information:

Mar. 30, 2012 -


Lacey Act a tangle of aquaculture regulation

Gibson guitar clashed with Lacey Act


David Bennett, Delta Farm Press


The 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.


And Mike 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 Farm Press 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:


On the Lacey Act…


“The 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.


“For the 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 wild.


“We must 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.


“The 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.


For more on the Gibson incident, see here.


“Well, 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.


“I’ll tell the committee about that.”


Is there a move to amend the Lacey Act?


“The 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 any.


“The 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.


“If I 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.


“The act 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.”


“That was changed in the 1990s and U.S. Fish and Wildlife has really stepped up the use of the Lacey Act.


“A fish 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.


“But 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.’


“That 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 fine.


“We 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 here) on it and concluded that farm-raised fish should be exempt from the Lacey Act.


“One of 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.


“If 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.”




Fish Hatchery Closure Possible Due to Drought


ATHENS—Texas 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.


“Although we 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.


“Although we 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.”


Located in 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.


Originally 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 Kemp.


“Severe drought 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.”


TPWD operates 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 continues.


“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 year.


“Largemouth 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 programs.”


February 16, 2012 - NAA Industry Update 


Five-Year Summary of

Seafood Trade Deficit Data


Please note 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.


The seafood 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 5-year summary.


Seafood trade deficit at $10.887 billion in 2011.







Fish/shellfish rank in deficit






Fish/shellfish value ($billion)







Next 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       


Largest Food 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    


Largest Deficit Contributor     (10000) Crude   (10000) Crude   (10000) Crude   (10000) Crude   (10000) Crude   (10000) Crude  


2nd Largest Deficit Contributor (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 - textile     


Largest Surplus Contributor     (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 foodgrains       

2011 Insights


Total trade deficit grew 14.4% over previous year.  Record High remains 2006.


(01000) Fish and shellfish deficit passes $10.89 billion mark (a 8.2% increase over 2009)


No "China-Effect" readily apparent from trade data.  Both imports from and exports to China increase to hold seafood trade deficit with China relatively stable.


(00000) Green coffee ($6.905 billion) surpasses (00190) Wine and related products ($6.767 billion) as #2 trade deficit contributor for first time.


Many agricultural categories post record surpluses or record deficits.


Major shifts to greater surplus noted in (10010) Fuel oil, (14270) Nonmonetary gold, (10020) Other petroleum products.


February 10, 2012 - NAA Industry Update 


USDA Seeking Stakeholder Input

RE: APHIS Reorganization


 USDA-APHIS 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 Responses may also be submitted via email to


SUPPLEMENTARY 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. 


In your opinion, what are the three to five most essential services APHIS provides and why? 


Please share 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 support? Why? 


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? 


2. Given 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 examples. 


3. Please 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. 


On-site 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 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. 


Persons 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.


January 26, 2012 - NAA Industry Update 


FDA Proposed Rule on

Import Tolerances


FDA is 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.


The January 25, 2012 FDA Federal Register Proposed Rule on "Import Tolerances for Residues of Unapproved New Animal Drugs in Food" is posted at:


The deadline for public comments is April 24, 2012.


Summary of the Proposed Rule:


A.     Scope (Proposed Sec. 510.201)


Proposed Sec. 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.


When 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.


January 4, 2012 - NAA Industry Update


NAA Announces Availability of

Narrated PowerPoint Presentation


The National 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.


The 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 pharmaceuticals.


The overall 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.


“U.S. Aquaculture: The New Face of Farming" can be viewed at  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



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