Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al
Filing
33
DECLARATION of Jennifer A. Sorenson in Support re: 19 MOTION for Summary Judgment.. Document filed by Center For Science In The Public Interest, Food Animal Concerns Trust, Natural Resources Defense Council, Inc., Public Citizen, Inc., Union Of Concerned Scientists, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Exhibit J, # 11 Exhibit K, # 12 Exhibit L, # 13 Exhibit M, # 14 Exhibit N, # 15 Exhibit O, # 16 Exhibit P, # 17 Exhibit Q, # 18 Exhibit R, # 19 Exhibit S, # 20 Exhibit T, # 21 Exhibit U, # 22 Exhibit V, # 23 Exhibit W, # 24 Exhibit X, # 25 Exhibit Y, # 26 Exhibit Z, # 27 Exhibit AA, # 28 Exhibit BB, # 29 Exhibit CC, # 30 Exhibit DD)(Sorenson, Jennifer)
EXHIBIT AA
TO DECLARATION OF
JENNIFER A. SORENSON
WHO 2011 Policy Brief
World Health Day 2011
4d. reduce use of AntimicrobiAls
in food-Producing AnimAls
Antibiotics are widely used in healthy food-producing animals to promote growth and prevent
disease. This practice favours the emergence and spread of resistant bacteria in both animal
and human populations.
WHY ADDRESSING THE USE
OF ANTIMICROBIALS IN FOODPRODUCING ANIMALS?
> The routine use of antimicrobials in vast numbers of healthy
animals is likely to result in the emergence and spread of antimicrobial-resistant bacteria, and cause resistant infections in
animals and humans.
> Resistant microorganisms carried by food-producing animals
can spread to humans through consumption of contaminated
food, from direct contact with animals, or by environmental
spread, for example in contaminated water.
> The genes coding for antimicrobial resistance can be transferred from microbes carried by animals to microbes that cause
disease in humans.
> Food animals and foods of animal origin are traded worldwide;
as a result, antimicrobial resistance (AMR) affecting the food
supply of one country becomes a potential problem for other
countries.
CHALLENGES TO OVERCOME
> Lack of information: data on the occurrence of resistance and
on antimicrobial use in animals are essential for risk analysis
and to assess the effectiveness of control measures. However,
few countries have systems to monitor antimicrobial resistance
and even fewer have systems to monitor the use of antimicrobials in animals.
> Lack of standardized data collection: the data collected are
often difficult to interpret and compare because the methods
used to obtain them are not standardized.
Examples
The use of a glycopeptide (avoparcin) as a growth promoter in food animals in Europe resulted in the
development of vancomycin-resistant Enterococci (VRE) in the commensal flora of food animals, on meat from
these animals and in the commensal flora of healthy humans, despite the limited use of glycopeptides such as
vancomycin only in hospitalized patients. A subsequent ban on the use of avoparcin in food animals in the
European Union reduced the occurrence of VRE in animals and its presence in the general population.
The use of fluoroquinolones (e.g. enrofloxacin) in food-producing animals has resulted in the development of
ciprofloxacin-resistant Salmonella, Campylobacter and Escherichia coli, which have caused human infections
that proved difficult to treat. In several instances, such bacteria have spread worldwide through travel and
food trade.
Policy PAckAge to combAt
AntimicrobiAl drug resistAnce
COMBAT DRUG RESISTANCE
No action today, no cure tomorrow
> Lack of intersectoral collaboration: without coordinated AMR
surveillance in bacteria from humans, food and animals it is
difficult to assess the public health impact of antimicrobial use
in food-producing animals and to take corrective measures.
> Inadequate training: lack of training on appropriate use of
antimicrobial agents in food-producing animals, and insufficient understanding of their potential contribution to AMR in
humans, are common among farmers, veterinary prescribers
and dispensers.
> Perverse incentives: the unnecessary use of antimicrobials
is often encouraged by financial incentives, such as achieving
sales profits by veterinarians, or perceived benefits, such as
promoting the growth of food-producing animals.
> Gaps in legal and regulatory controls: insufficient legislation
and regulation to restrict the approved use of licensed antimicrobials, and to control the supply of antimicrobials, facilitates
the excessive use of antibiotics.
CORE ACTIONS
A. Provide nAtionAl leAdershiP And Promote
intersectorAl collAborAtion
c. strengthen surveillAnce And monitoring
1)
Create national systems to monitor antimicrobial usage in foodproducing animals.
2)
Develop national integrated surveillance programmes to
monitor current and emerging AMR patterns (including quantitative susceptibility data for zoonotic pathogens and indicator bacteria). Surveillance should involve close collaboration
between public health, veterinary and food laboratories.
3)
Set up a multidisciplinary task force involving authorities in
public health, veterinary medicine and food safety to act on
the surveillance data for identification of trends, assessment of
risks and timely implementation of focused interventions.
4)
Engage in the development and adoption of standardized protocols to facilitate global harmonization in surveillance of antimicrobial usage in humans and animals, and of antimicrobial
resistance.
d. Promote educAtion And trAining on
AntimicrobiAl use in food-Producing AnimAls
2)
Establish a formal mechanism of interaction between the
Ministry of Health and other relevant ministries and authorities
to address the issue of AMR in the agricultural sector.
Develop and implement national guidelines on prudent use
of antimicrobials in food-producing animals, with multidisciplinary involvement, taking into consideration antimicrobials
categorized as critically important for human medicine.
2)
Provide training for veterinarians and farmers on the use of these
guidelines; and implement auditing and feedback to veterinarians and agricultural producers to improve compliance.
3)
1)
1)
Develop and implement education strategies that emphasize the
importance and benefits of prudent use principles, and provide
relevant information on AMR to producers, stakeholders and the
public.
4)
Facilitate implementation of the Codex Alimentarius and OIE
(World Organisation for Animal Health) guidelines related to
antimicrobial resistance.
Include agricultural and veterinary authorities in the national
intersectoral steering committee on AMR.
b. creAte And enforce An enAbling regulAtory
frAmework
1)
Establish a regulatory framework for authorization and control
of the quality of veterinary medicines.
2)
Introduce pre-licensing safety evaluation of antimicrobials for
veterinary use, with consideration of potential resistance to
drugs used in human medicine.
3)
Terminate non-therapeutic use of antimicrobials, such as the
use of antimicrobials as growth promoters.
e. reduce the need for AntimicrobiAls through
better AnimAl husbAndry
4)
Restrict or eliminate the use in food-producing animals of antimicrobials identified as critically important in human medicine,
especially the use of fluoroquinolones, and third- and fourthgeneration cephalosporins.
1)
Introduce measures to improve animal health, and reduce the
need for antimicrobial treatment, including application of effective vaccines.
2)
Improve health management for food animal production by
ensuring good hygiene practices and compliance with good
farming practices.
5)
Require obligatory prescriptions for all antimicrobials used for
disease control in food-producing animals.
.
For more information, go to: http://www.who.int/world-health-day/2011
© World Health Organization 2011. All rights reserved.
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