Future Expectations and Benefits
KƚŚĞƌ ĐŚĂŶŐĞƐ ŝŶ ŝŶƐƉĞĐƚŝŽŶƐ ĂƌĞ ĞdžƉĞĐƚĞĚ͘ /ŶĚƵƐƚƌLJ
ŚĂƐ ĞŶĐŽƵƌĂŐĞĚ & ĂŶĚ ƐƚĂƚĞ ĂŐĞŶĐŝĞƐ ƚŽ ĐŽŶƟŶƵĞ ƉƌŝŽƌ
ŶŽƚŝĨŝĐĂƚŝŽŶ ŽĨ ŝŶƐƉĞĐƚŝŽŶƐ ƚŚĂƚ ĨĞĚĞƌĂů ĂŶĚ ƐŽŵĞ ƐƚĂƚĞ
ŝŶƐƉĞĐƚŽƌƐďĞŐĂŶŝŶϮϬϮϬ͘dŚĞŝŶĐƌĞĂƐĞĚĞĸĐŝĞŶĐLJĂŶĚƟŵĞ
ƐĂǀŝŶŐƐ ďLJ ƐƵĐŚ ŶŽƟĮĐĂƟŽŶƐ ďĞŶĞĮƚ ďŽƚŚ ŝŶƐƉĞĐƚŽƌƐ ĂŶĚ
ƉůĂŶƚƐ͘ /ŶƐƉĞĐƟŽŶƐ ŝŶ ƚŚĞ ĨƵƚƵƌĞ ǁŝůů ďĞ ͞ĐŽŵƉƌĞŚĞŶƐŝǀĞ͕͟
ŵĞĂŶŝŶŐ Ă ƌĞŶĚĞƌŝŶŐ ƉůĂŶƚ ǁŝůů ůŝŬĞůLJ ďĞ ŝŶƐƉĞĐƚĞĚ ĨŽƌ
ĂĚŚĞƌĞŶĐĞ ƚŽ Ăůů ĂƉƉůŝĐĂďůĞ & ƌĞŐƵůĂƟŽŶƐ ŝŶĐůƵĚŝŶŐ ^͕
'DW͕,ͬW͕ĂŶĚƐĂŶŝƚĂƌLJƚƌĂŶƐƉŽƌƚĂƟŽŶƌƵůĞƐĐŽŶĐƵƌƌĞŶƚůLJ͘
ZĞůĂƚŝŽŶƐŚŝƉƐ ďĞƚǁĞĞŶ ĂŶŝŵĂů ĨŽŽĚ ŝŶĚƵƐƚƌŝĞƐ ĂŶĚ
ƌĞŐƵůĂƚŽƌƐ͕ ŽĨƚĞŶ ĚĂŵĂŐĞĚ ďLJ ƌĞĐĂůůƐ ĂŶĚ ĨŽŽĚ ƐĂĨĞƚLJ
ŝŶǀĞƐƟŐĂƟŽŶƐ͕ŚĂǀĞďĞĞŶƌĞƉĂŝƌĞĚĂŶĚĞŶŚĂŶĐĞĚďLJǁŽƌŬŝŶŐ
ƚŽŐĞƚŚĞƌ ƚŽ ŵĂŬĞ &^D ƉƌĂĐƚŝĐĂů ĂŶĚ ĨĞĂƐŝďůĞ͘ dŚĞƐĞ
ƌĞůĂƟŽŶƐŚŝƉƐ ŚĂǀĞ ŝŶĐƌĞĂƐĞĚ ƌĞŐƵůĂƚŽƌƐ͛ ƵŶĚĞƌƐƚĂŶĚŝŶŐ ŽĨ
ĂŶŝŵĂůĨŽŽĚŝŶŐƌĞĚŝĞŶƚƐƵƉƉůŝĞƌƐƐƵĐŚĂƐƌĞŶĚĞƌĞƌƐ͕ĂŶĚŚŽǁ
ƚŚĞLJĂĐĐŽŵƉůŝƐŚƚŚĞŝƌŝŵƉŽƌƚĂŶƚƌŽůĞƐ͘
tŚŝůĞƌĞƐƉŽŶĚŝŶŐƚŽĂŶĚĐŽŵƉůLJŝŶŐǁŝƚŚ&^DŚĂƐďĞĞŶ
ƟŵĞĐŽŶƐƵŵŝŶŐĂŶĚƐƚƌĞƐƐĨƵů͕ŶŽƚƚŽŵĞŶƟŽŶĞdžƉĞŶƐŝǀĞ͕ĂŶĚ
ĐŽŶƐŝĚĞƌŝŶŐƚŚĂƚĨŽŽĚŚĂnjĂƌĚƐĐĂƵƐĞĚďLJƌĞŶĚĞƌĞĚƉƌŽĚƵĐƚƐ
ƉƌŝŽƌƚŽ&^DǁĞƌĞŶĞĂƌůLJŶŽŶĞdžŝƐƚĞŶƚ͕&^DŚĂƐďĞĞŶŐŽŽĚ
ĨŽƌƚŚĞŝŶĚƵƐƚƌLJ͘dŚĞŶĞǁůĂǁŵĂĚĞŵƵĐŚŽĨƚŚĞRendering
ŽĚĞŽĨWƌĂĐƟĐĞŵĂŶĚĂƚŽƌLJ͘&^DĨŽƌĐĞĚƐŽŵĞĐŚĂŶŐĞƐƚŚĂƚ
ǁŽƵůĚŚĂǀĞďĞĞŶĚĞŵĂŶĚĞĚďLJĐƵƐƚŽŵĞƌƐĂŶLJǁĂLJ͘ZĞŶĚĞƌĞƌƐ͛
ŵŽƐƚ ůƵĐƌĂƟǀĞ ŵĂƌŬĞƚ͕ ƉĞƚ ĨŽŽĚ͕ ŝƐ ŝŶĐƌĞĂƐŝŶŐůLJ ĐƌŝƟĐĂů ĂŶĚ
ĚĞŵĂŶĚŝŶŐ͘ &^D ĐŽŵƉůŝĂŶĐĞ ŚĂƐ ͞ƚĂŬĞŶ ƚŚĞ Ăŝƌ ŽƵƚ͟ ŽĨ
ƐŽŵĞ ĐƌŝƟĐŝƐŵƐ ĨƌŽŵ ĂĐƟǀŝƐƚƐ ĐůĂŝŵŝŶŐ ƉĞƚ ĞŶĚĂŶŐĞƌŵĞŶƚ
ĨƌŽŵ ďLJͲƉƌŽĚƵĐƚƐ͘ ƩĞŶƟŽŶ ƚŽ ĚĞƚĂŝů ĂŶĚ ƌĞĐŽƌĚƐ ƌĞƋƵŝƌĞĚ
ďLJ&^DƐĞƚƚŚĞƐƚĂŐĞĨŽƌŝŶĐƌĞĂƐĞĚĐŽŶƚƌŽůŽĨǀĂƌŝĂďůĞƐĂŶĚ
ƉůĂŶƚƉƌŽĮƚĂďŝůŝƚLJ͘ŽůůĞĐƟǀĞůLJƌĞƐƉŽŶĚŝŶŐƚŽƚŚĞĐŚĂůůĞŶŐĞƐ
ĂŶĚ ƉŽƚĞŶƟĂů ŝŵƉĂĐƚƐ ŽĨ &^D ŚĂƐ ŝŶĐƌĞĂƐĞĚ ƚŚĞ ďŽŶĚŝŶŐ
ĂŵŽŶŐĐŽŵƉĞƟƟǀĞƌĞŶĚĞƌĞƌƐŵƵĐŚĂƐƌĞƐƉŽŶĚŝŶŐƚŽ^ĚŝĚ
ϭϴLJĞĂƌƐĂŐŽ͘
dŚĞƌĞŶĚĞƌŝŶŐŝŶĚƵƐƚƌLJƌĞƐƉŽŶĚĞĚƚŽ&^DĂƐŝƚŚĂƐƚŽ
ŽƚŚĞƌ ŵĂũŽƌ ĐŚĂůůĞŶŐĞƐ ƚŚƌŽƵŐŚŽƵƚ ŝƚƐ ŚŝƐƚŽƌLJͶǁŝƚŚ ŐŽŽĚ
ũƵĚŐĞŵĞŶƚ͕ĐŽŽƉĞƌĂƟŽŶ͕ĂŶĚƌĞƐƉĞĐƚĨŽƌƚŚĞůĂǁǁŚŝůĞĂƐŬŝŶŐ
ƚŽƵŐŚƋƵĞƐƟŽŶƐĂŶĚƉĂƌƟĐŝƉĂƟŶŐŝŶĐŽŶƐƚƌƵĐƟǀĞĐƌŝƟĐŝƐŵ͘dŚĞ
ƌĞƐƵůƚŚĂƐďĞĞŶĂǁŽƌŬĂďůĞƐĞƚŽĨŶĞǁƌĞŐƵůĂƟŽŶƐƚŚĂƚĚŽ͕ŝŶ
ĨĂĐƚ͕ ĞŶŚĂŶĐĞ ĂŶŝŵĂů ĨŽŽĚ ƐĂĨĞƚLJ ĂŶĚ Ă ƐƚƌŽŶŐĞƌ ƌĞŶĚĞƌŝŶŐ
ŝŶĚƵƐƚƌLJ͘ R
Table 2. Main reasons for rule violations (from all
inspected animal food establishments)
CGMP rules
Personnel failed to use hygienic practices to prevent
contamination of animal food
Failure to keep and maintain grounds in a manner to prevent
adulteration of animal food
Failure to hold animal food under proper conditions (i.e.,
refrigeration, when required)
Failure to keep legible records and signed by responsible person
Occasional violation regarding utensils, pest control, or
handling rework
HA/PC rules
Failure to identify and implement preventive controls to ensure
hazards are minimized or controlled
Failure to develop a food safety plan
Failure to evaluate all hazards for all types of animal food
produced
Process controls failed to perform within parameters needed
Failure to verify that preventive controls are working
Failure to reanalyze food safety plan when required
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