Monday, February 1, 2016
RISK MANAGEMENT PLAN
RISK MANAGEMENT PLAN
Evidence of and understanding of an integrated risk management plan and a description of counter parties on whom the operation is dependent will also need to be provided. Finally, farmers will increasingly be required to provide evidence of compliance with sustainability and environmental requirements. Given all these factors, we may be looking at several years of tighter credit. If a lending institution fails or gets in trouble and is acquired by another lender, farmers who finance with the former lender are almost always subject to higher credit standards — not because the new lender is tougher, but because the former lender was too lax.
In a case where a farmer’s loans were too large to be handled by the originating lender, a pull-out by one of the participating lender(s) can be even more devastating, because there will be fewer, if any, lenders willing to take their place, and it could become a house of cards if the lender can’t find a replacement participating lender.
Why agriculture is a 'dream job' for tech enthusiasts By Ben Potter, AgWeb.com January 21, 2016 | 11:15 am EST
Technology and agriculture are blending together at a rapid pace – so much so that the time is ripe for a multitude of new career opportunities, according to Charlie O’Brien, AEM senior vice president and ag sector lead.
“Agriculture has evolved into an incredibly sophisticated industry, a dream job for technology enthusiasts,” he says. “No wonder companies like Google are looking at our sector with great interest.”
He says these tech innovations span from the plants where equipment is manufactured to the farm itself. A trip to a manufacturing plant today will show visitors a world of robotics, 3D modeling and 3D printing, O’Brien says. He also envisions a world not far from now where machinery dealerships and even some farms will use 3D printers to manufacture parts on-demand.
Additionally, software engineers and outside companies are figuring out how to harness the powers of big data to make it smart data, he adds.
Read more from AgWeb.com.
Veterinary Feed Directive will impact whole livestock industry, but many aren't aware of the regulation
Veterinary Feed Directive will impact whole livestock industry, but many aren't aware of the regulation
Last year, the Food and Drug Administration implemented the Veterinary Feed Directive, or VFD, which will require farmers to get prescriptions on most antibiotics they would normally get over the counter for their livestock feed.
Christine GabelExpand Photo
Brett Kaysen
To learn more about the Veterinary Feed Directive, go to the Food and Drug Administration’s website at www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm071807.htm. ">www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm071807.htm.
Regulated under the VFD
The Food and Drug Administration implemented the Veterinary Feed Directive, or VFD, which will require farmers to get prescriptions on most antibiotics that they would normally get over the counter for their livestock feed. The program will begin Jan. 1. 2017. Here’s list of regulated antibiotics:
» Aminoglycosides
» Diaminopyrimidines
» Lincosamides
» Macrolides
» Penicillins
» Streptogramins
» Sulfas
» Tetracycline
What is not regulated under the VFD:
» Ionophores
» Bacitracin
» Bambermycins
» Carbadox
Other nonantimicrobial drugs or other drugs that are already regulated.
When the Veterinary Feed Directive goes into effect in 2017, it will impact nearly everyone in the livestock industry.
But at the Colorado Farm Show this week, when Christine Gabel, territory business manager with animal health company Zoetis asked a room of farmers and ranchers if they’d heard of it, she was met with silence. Most looked to their neighbors, foreheads crinkled under the brims of cowboy and baseball hats.
“It’s going to impact all of us,” Gabel said, surprised and concerned so few people knew about the regulation.
Last year, the Food and Drug Administration implemented the Veterinary Feed Directive, or VFD, which will require farmers to get prescriptions on most antibiotics they would normally get over the counter for their livestock feed.
Farmers worry this could have dramatic effects on their operations.
Come Jan. 1, 2017, every livestock producer who uses an antibiotic considered important to human health, such as penicillin or sulfa, will have to comply. The regulation covers antimicrobial drugs administered via feed or water, but not via injection. It also will hit every retailer that sells these products and every veterinarian.
The directive was created to limit the use of antibiotics only for disease treatment, control and prevention, rather than for growth or maintenance purposes, Gabel said.
According to the Centers for Disease Control, every year in the U.S., at least 2 million people are infected by bacteria resistant to antibiotic treatment, and more than 20,000 people die from these infections. The directive was put in place to mandate judicious antibiotic use in livestock to reduce the risk of antibiotic resistant bacteria.
That’s something nearly everyone should be able to get behind, said Brett Kaysen, diary productivity specialist at Zoetis.
“At the end of the day, really what we want is the most healthy animals on the farm level to support the most healthy protein going into the food chain,” Kaysen said.
Gabel gave a presentation on the first day of the show, and again with Kaysen on the second day of the show, which concluded Thursday. Both of them emphasized animal health already is ranchers’ priority; this is just changing the system.
So how will this new requirement look?
As an example, when a dairy cow calves, after the initial feeding, the mother’s milk is too valuable for the calf to nurse. That milk is how the farmer makes his money, so the calf goes on a milk replacer, which often is medicated. Medicated milk replacer is one of the feed-grade antibiotic products that falls under the Veterinary Feed Directive. For the farmer to put the calf on this milk replacer, he must get a prescription from his veterinarian, fill it at a distributor who has registered that specific prescription with the FDA and ensured every qualification of the directive is met, then keep the records of that transaction for two years.
What happens when the dairy cow goes into labor unexpectedly during a blizzard and the prescription isn’t ready for the calf’s arrival? Filling a prescription isn’t a same-day process, said Stuart Gebauer, sales manager in the feed division for Agfinity. Farmers and ranchers won’t be able to call distributors with last-minute requests like these under the new regulation.
It also means the relationship between producers and veterinarians must be stronger, Gabel said. Veterinarians will be held liable for abuses of directive prescriptions, so if they don’t think a producer is using an antibiotic properly, or even if they don’t have a good understanding of their operation, they might not issue the prescription to begin with.
“(They) need to be comfortable with you as an operator and your operation,” Kaysen said.
Gabel said now is the time to start fostering those relationships. Since the VFD regulation will be in effect by the start of 2017, there’s time for both producers and vets to ask each other their questions.
In one of the presentations, Laura Negley of Eads asked what this meant for rural areas with shortages of veterinarians. Gabel didn’t have the answer, but she said it’s an issue that needs to be addressed in the coming year so livestock producers in small counties aren’t left behind.
Several producers also raised concerns about whether the costs of the oversight and potential audits will trickle down to the rancher. The answers on this aren’t clear either, and likely won’t be until the regulation kicks in.
Nevertheless, Gabel said it’s important to raise awareness now, so there are fewer surprises in 2017.
“It’s coming,” she said, “whether we’re ready or not.”
Veterinary Feed Directive
Complete 27 page rule available at:
https://www.gpo.gov/fdsys/pkg/FR-2015-06-03/html/2015-13393.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-06-03/pdf/2015-13393.pdf
Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
[Rules and Regulations]
[Pages 31707-31735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13393]
Veterinary Feed Directive
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending its animal
drug regulations regarding veterinary feed directive (VFD) drugs. FDA's
current VFD regulation established requirements relating to the
distribution and use of VFD drugs and animal feeds containing such
drugs. This amendment is intended to improve the efficiency of FDA's
VFD program while protecting human and animal health.
DATES: This rule is effective October 1, 2015.
FOR FURTHER INFORMATION CONTACT: Sharon Benz, Center for Veterinary
Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-402-5939, email: Sharon.Benz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Executive Summary
Purpose of Final Rule
The purpose of this rulemaking is to revise FDA's VFD regulations
to improve the efficiency of the VFD program while continuing to
protect public health (human and animal health).
In 1996, Congress enacted the Animal Drug Availability Act (ADAA)
(Pub. L. 104-250) to facilitate the approval and marketing of new
animal drugs and medicated feeds. In passing the ADAA, Congress created
a new regulatory category for certain animal drugs used in or on animal
food (animal feed) called veterinary feed directive drugs (or VFD
drugs). VFD drugs are new animal drugs intended for use in or on animal
feed which are limited to use under the professional supervision of a
licensed veterinarian. Any animal feed containing a VFD drug can only
be fed to animals based upon an order, called a veterinary feed
directive (VFD), issued by a licensed veterinarian in the course of the
veterinarian's professional practice. FDA published final regulations
implementing the VFD-related provisions of the ADAA in 2000 (see Sec.
558.6 (21 CFR 558.6)) (65 FR 76924, December 8, 2000). In the decade
since FDA published its VFD regulations, various stakeholders have
informed the Agency that the existing VFD process is overly burdensome.
In response to those concerns, FDA published several documents inviting
public input on ways to improve the VFD process, including an advance
notice of proposed rulemaking (ANPRM) (75 FR 15387, March 29, 2010)
(March 2010 ANPRM); draft regulatory text for proposed regulation (77
FR 22247, April 13, 2012) (April 2012 draft proposed regulation); and a
notice of proposed rulemaking (NPRM) (78 FR 75515, December 12, 2013)
(December 2013 NPRM).
The VFD rule is the third of three core documents that FDA is using
to announce and implement its policy framework for the judicious use of
medically important antimicrobial drugs in food-producing animals. The
first document, Guidance for Industry (GFI) #209, entitled ``The
Judicious Use of Medically Important Antimicrobial Drugs in Food-
Producing Animals,'' published April 2012, set forth FDA's framework
for instituting several key measures for ensuring the appropriate or
judicious use of medically important antimicrobial drugs in food-
producing animals. These measures include eliminating the feed and
water use of medically important antimicrobial drugs for production
purposes in food-producing animals and bringing all remaining
therapeutic uses under the oversight of licensed veterinarians. The
second document, GFI #213, entitled ``New Animal Drugs and New Animal
Drug Combination Products Administered in or on Medicated Feed or
Drinking Water of Food-Producing Animals: Recommendations for Drug
Sponsors for Voluntarily Aligning Product Use Conditions with GFI
#209,'' published December 2013, outlined a detailed process and
timeline for implementing the measures identified in GFI #209. Once GFI
#213 is fully implemented, affected feed-use antimicrobial drugs are
expected to transition from over-the-counter (OTC) to VFD marketing
status. Given that most of the products affected by this effort are
feed-use antimicrobial drugs this VFD regulation plays an important
role since it outlines the requirements associated with veterinary
authorization, distribution, and use of VFD drugs in animal feed.
The VFD drug process as outlined in this final rule includes
important controls regarding the distribution and use of VFD drugs. In
addition to providing accountability, this final rule also updates the
VFD requirements to improve the efficiency of the process. These
regulatory enhancements are important for facilitating the transition
of a large number of OTC feed-use antimicrobial drugs to their new VFD
status.
FDA intends to use a phased enforcement strategy for implementation
of this final rule as OTC drugs become VFD drugs under GFI #213. FDA
first intends to provide education and training for stakeholders
subject to this final rule such as veterinarians, clients (animal
producers), feed mill distributors and other distributors. Such
education and training efforts are important for supporting effective
implementation and compliance with the final rule. FDA will then engage
in risk-based general surveillance, as well as for-cause inspection
assignments. FDA intends to use information such as history of VFD use
and the volume of VFD feed being produced to focus inspectional
resources within the industry based on risk. FDA anticipates that it
will utilize various sources for obtaining such information including
such sources as FDA food and drug registration information, feed mill
licensing information, the VFD distributor notifications FDA receives,
and VFD distribution records maintained by drug sponsors and VFD
distributors.
The provisions included in this final rule are based on stakeholder
input received in response to multiple opportunities for public
comment, including the March 2010 ANPRM, April 2012 draft proposed
regulation, and the December 2013 NPRM.
Summary of Major Provisions
This final rule makes several important changes from the proposed
rule and several major changes to the current VFD regulations in part
558 (21 CFR part 558):
The definition of ``Category II'' in part 558 is revised
to remove the automatic Category II designation for VFD drugs. Instead,
the categorization of VFD drugs will be determined on a case-by-case
basis based on the likelihood that the particular drug at issue will
produce an unsafe residue in edible products derived from treated
animals, as is currently the case for non-VFD feed use drugs.
The definition of veterinary feed directive (VFD) drug is
revised to simply refer to the statutory definition to provide further
clarity.
The proposed definition of combination veterinary feed
directive (VFD) drug is revised to reflect the
[[Page 31709]]
changes to the veterinary feed directive (VFD) drug definition.
The proposed definition of a ``veterinary feed directive''
is revised to remove language that is duplicated in the
responsibilities of a veterinarian issuing a VFD.
The proposed definition of the term ``distributor'' is
revised to use the word ``distributes'' instead of the word
``consigns'' as had been proposed.
The regulatory text proposed for Sec. 558.6(a)(4) and
(b)(8) is revised to clarify that the veterinarian is required to keep
the original VFD (in hardcopy or electronically) and the distributor
and client must keep a copy of the VFD (in hardcopy or electronically).
The current requirement that copies of the VFD and records
of the receipt and distribution of VFD feed must be kept for a period
of 2 years is retained instead of being changed to 1 year as was
proposed.
The final rule provides that the veterinarian must issue
the VFD in the context of a valid veterinarian-client-patient
relationship (VCPR) as defined by the State requirements applicable to
where the veterinarian practices veterinary medicine. In States that
lack appropriate VCPR requirements applicable to VFDs, the veterinarian
must issue the VFD consistent with the Federally defined VCPR standard,
which is set forth in FDA's regulations at Sec. 530.3(i) (21 CFR
530.3(i)).
The VFD expiration date requirement in the final rule
specifies that this is the date that authorization to feed the VFD feed
to animals expires. Animals must not be fed the VFD feed after the
expiration date of the VFD.
The VFD requirement for approximate number of animals in
the final rule specifies how the approximate number of animals should
be determined.
The final rule clarifies the affirmation of intent
statements to be used in VFDs issued by licensed veterinarians to
indicate whether a VFD drug may be used in conjunction with another
drug in an approved, conditionally approved, or indexed combination VFD
feed.
The final rule clarifies the recordkeeping requirements to
differentiate what records are required to be kept for distributors who
manufacture VFD feed and those who do not manufacture the VFD feed.
Costs and Benefits
The estimated one-time costs to industry from this final rule are
$1,411,000, most of which are simply costs to review the rule and
prepare a compliance plan. This equates to annualized costs of about
$201,000 at a 7 percent discount rate over 10 years. We estimate that
the government costs associated with reviewing the six VFD drug
labeling supplements that are expected to be submitted by the three
current VFD drug sponsors to be $1,900.
The expected benefit of this final rule is a general improvement in
the efficiency of the VFD process. FDA estimates the annualized cost
savings associated with the more efficient requirements of the VFD
process to be $13,000 over 10 years at a 7 percent discount rate
(annualized at $11,000 over 10 years at a 3 percent discount rate).
Additionally, the reduction in veterinarian labor costs due to this
rule is expected to result in a cost savings of about $7.87 million
annually.
Table of Contents
I. Background
A. History
B. Judicious Use Policy for Medically Important Antimicrobials
II. Overview of the Final Rule
III. Comments on the Proposed Rule
A. Definitions Section (Sec. 558.3)
B. Veterinary Feed Directive Drugs (Sec. 558.6)
IV. Legal Authority
V. Final Regulatory Impact Analysis
VI. Paperwork Reduction Act of 1995
A. Reporting Requirements
B. Recordkeeping Requirements
C. Third-Party Disclosure Requirements
VII. Environmental Impact
VIII. Federalism
IX. References
III. Comments on the Proposed Rule
This section summarizes comments FDA received in response to the
December 2013 NPRM and the Agency's response to those comments. FDA
received about 2,000 individual comments submitted to the docket on the
December 2013 NPRM. Some of the comments contained signatures by
multiple individuals or organizations. Comments were received from
veterinary, feed manufacturing, and animal production associations, as
well as consumer advocacy groups and individuals. Many of the comments
received from veterinarian, feed manufacturing, animal production
associations, and individuals generally supported the changes and
requested some additional changes or clarification on particular
issues. Many of the comments received from consumer advocacy groups and
individuals raised concerns over whether the changes would sufficiently
protect public health. FDA is making changes in the final rule to
address these concerns where the Agency has determined such changes to
be appropriate.
USDA Announces Commodity Credit Corporation Lending Rates for February 2016
USDA Announces Commodity Credit Corporation Lending Rates for February 2016
Release No. 0006.16
Contact:Isabel Benemelis
(202) 720-7809
WASHINGTON, Feb. 1, 2016 — The U.S. Department of Agriculture's Commodity Credit Corporation (CCC) today announced interest rates for February 2016. The CCC borrowing rate-based charge for February is 0.625 percent, unchanged from 0.625 percent in January.
The interest rate for crop year commodity loans less than one year disbursed during February is 1.625 percent, unchanged from 1.625 percent in January.
Interest rates for Farm Storage Facility Loans approved for February are as follows, 2.000 percent with seven-year loan terms, unchanged from 2.000 percent in January; 2.125 percent with 10-year loan terms, down from 2.250 percent in January and; 2.250 percent with 12-year loan terms, down from 2.375 percent in January. The interest rate for 15-year Sugar Storage Facility Loans for February is 2.375 percent, down from 2.500 percent in January.
Further program information is available from USDA Farm Service Agency's (FSA) Financial Management Division at 202-772-6041.
NMSU researchers investigate how super-hot peppers pack their powerful punch
NMSU researchers investigate how super-hot peppers pack their powerful punch
DATE: 02/01/2016
WRITER: Justin Bannister, 575-646-5981, jbannist@nmsu.edu
CONTACT: Danise Coon, 575-646-3028, hotchile@nmsu.edu
Researchers at New Mexico State University’s Chile Pepper Institute have discovered that super-hot chile peppers, those with more than one million Scoville Heat Units, are built differently than other peppers. Unlike regular chile peppers, super-hot peppers make the most of the interior space they have available, which can lead to some serious heat.
“What we were interested in finding was why super-hot chile peppers are able to get that hot,” said Paul Bosland, an NMSU Regents Professor and director of the university’s Chile Pepper Institute.
According to Bosland, it has been known that a chile pepper’s heat comes from the chemical compound capsaicin, and that capsaicinoids are found in yellow-colored sacs called vesicles. In most chile peppers, the capsaicinoid vesicles are attached to the fruit’s placenta, where the seeds are located.
With super-hot peppers, those sacs are also found on the fruit wall, and in larger quantities. This gives the pepper far more surface area to pack in capsaicinoid vesicles and to turn up the heat. Peter Cooke, with the NMSU Core University Research Resources Laboratory, was able to make the capsaicinoid sacs fluoresce in both jalapeno peppers and Trinidad Moruga Scorpion peppers and then examined the fruit with university’s electron microscope.
“There, you could see that the jalapeno was only fluorescing on the placenta,” Bosland said, “while the super-hots would fluoresce all over the wall. It’s a very dramatic image to see. Right now, we’re assuming this is a genetic mutation in super-hots because we’ve never seen this in wild chile peppers.”
Bosland said this information can help plant breeders in selecting for new chile pepper varieties that could potentially lead to chile peppers with double the heat of today’s hottest.
“We’ll probably see someone get a three million or four million Scoville Heat Unit fruit down the road,” he said. “This could be particularly helpful for the extraction industry, companies that extract those heat compounds for use in medicine.”
The Chile Pepper Institute will host its 2016 New Mexico Chile Conference this week, Feb. 1 and 2 at Hotel Encanto de Las Cruces. For more information, visit http://www.chilepepperinstitute.org/events.
- 30 -
Follow NMSU News on Twitter: http://twitter.com/nmsunews
Follow NMSU News on Facebook: http://www.facebook.com/NMSUNews
Zika Virus and livestock.
Dr. Carol Sutherland sent this to me so I am passing it along.
Digging around on the CDC website---which was just updated today, so ‘news is poppin’…..
Zika Virus originated in Africa and is named for the Zika Forest region in Uganda. The Zika virus infection was described and named in 1947. In Africa at that time---the virus was assumed to come from native animals---so it was termed ‘enzootic.’ What kind(s) of animals were considered original hosts---no idea.
Now that it’s in the news in the New World, I haven’t found any references to it associated with any animals---wild or domestic---on this side of the planet. From what I gather, it wouldn’t make a lot of difference since there’s no treatment for the infection in humans and development of any vaccine is probably years away.
For that matter, it’s still a hypothesis that Zika in pregnant women is responsible for microcephaly in their infants---but with the sheer numbers of babies in Brazil, Colombia and now a few in the U.S.----it sure looks plausible.
BTW---The distribution maps for Aedes (now called Ochlerotatus---but who remembers that?) aegypti (‘yellow fever mosquito’) show it across a broad area of southern NM, angling towards the northeast. There are two locales in NM considered to have Aedes albopictus, the Asian tiger mosquito---Eddy Co. and probably the ABQ metro area. These are considered---right now---the likely candidates for being Zika vectors.
But according to CDC---as of this morning---these vectors in the U.S. are most likely moving people-affecting viruses from one person to another; no animals have been considered as reservoirs or susceptible to these viruses. We’re safe for the time being……….
Subscribe to:
Posts (Atom)