[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Rules and Regulations]
[Pages 46570-46577]
From the Federal Register Online via the Government Publishing Office 
[FR Doc No: 2016-16904]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 309

[Docket No. FSIS-2014-0020]
RIN 0583-AD54


Requirements for the Disposition of Non-Ambulatory Disabled Veal 
Calves

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its 
regulations on ante-mortem inspection to remove a provision that 
permits establishments to set apart and hold for treatment veal calves 
that are unable to rise from a recumbent position and walk because they 
are tired or cold. FSIS is also amending its regulations to require all 
non-ambulatory disabled cattle to be promptly disposed of after they 
have been condemned. In addition, after review and consideration of 
comments to the proposed rule, FSIS is amending the regulations by 
removing a provision that requires ante-mortem inspection to be 
conducted in pens. This final rule makes clear that FSIS inspectors 
have the authority to conduct ante-mortem inspection and condemn non-
ambulatory disabled veal calves the moment they arrive on the premises 
of the establishment. These amendments will improve compliance with the 
Humane Methods of Slaughter Act of 1978 (HMSA) and the humane slaughter 
implementing regulations. The amendments will also improve the Agency's 
inspection efficiency by eliminating the time that FSIS inspectors 
spend re-inspecting non-ambulatory disabled veal calves.

DATES: Effective Date: September 16, 2016.

FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph. D., Assistant 
Administrator, Office of Policy and Program Development, Food Safety 
and Inspection Service, U.S. Department of Agriculture, 1400 
Independence Avenue SW., Washington, DC 20250-3700; Telephone (202) 
205-0495; Fax (202) 720-2025.

SUPPLEMENTARY INFORMATION: 

Background

    Under 9 CFR 309.3(e), non-ambulatory disabled cattle that are 
offered for slaughter, including those that have become non-ambulatory 
disabled after passing ante-mortem inspection, must be condemned and 
disposed of properly. However, under 9 CFR 309.13(b), non-ambulatory 
disabled veal calves that are able to rise from a recumbent position 
and walk after they have been set aside and warmed or rested, and that 
are found to be otherwise free from disease, may be slaughtered for 
human consumption under appropriate FSIS supervision.
    On May 13, 2015, FSIS published the proposed rule ``Requirements 
for the Disposition of Non-Ambulatory Disabled Veal Calves'' (80 FR 
27269). FSIS proposed to amend 9 CFR 309.13(b) to remove the set-aside 
provision. FSIS also proposed to amend 9 CFR 309.3(e) to require all 
condemned cattle to be promptly disposed of in accordance with 9 CFR 
309.13. Under the proposed rule, all non-ambulatory disabled cattle 
would be condemned and promptly euthanized.
    As FSIS explained in the proposed rule, in November 2009, the 
Humane Society of the United States (HSUS) filed a petition requesting 
that FSIS amend 9 CFR 309.13(b) to remove the provision that allows 
veal calves that are non-ambulatory disabled because they are tired or 
cold to be set aside for treatment and re-inspected at a later time 
(the set-aside provision).\1\ The petition stated that the set-aside 
provision is inconsistent with the

[[Page 46571]]

language and intent of the HMSA because it fails to ensure that the 
handling of livestock in connection with slaughter be carried out only 
by humane methods (see 7 U.S.C. 1902). The petition asserted that the 
set-aside provision creates an incentive for establishments to use 
inhumane methods to get non-ambulatory disabled veal calves to rise for 
re-inspection. Furthermore, the petition stated that removing the set-
aside provision would eliminate the uncertainty of determining whether 
veal calves are non-ambulatory disabled because they are tired or cold 
or because they are injured or sick, thereby ensuring the appropriate 
disposition of these calves. Finally, the petition stated that 
eliminating the time that FSIS inspectors spend re-inspecting calves 
would improve inspection efficiency (80 FR 27269).
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    \1\ The petition is available on the FSIS Web site at http://www.fsis.usda.gov/wps/wcm/connect/9ddd8b7c-983f-4cb1-83e8-9e545e9345d0/Petition_HSUS_Humane_Handling.pdf?MOD=AJPERES.
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    The petition referred to video footage from an HSUS undercover 
investigation at an official veal slaughter establishment conducted in 
August and September 2009. The video footage documented incidents in 
which establishment personnel attempted to force non-ambulatory 
disabled veal calves to rise by kicking, prodding, and dragging the 
calves to their feet. After release of this video footage, FSIS 
conducted its own investigation that found the establishment repeatedly 
failed to handle non-ambulatory disabled veal calves in a humane 
manner. FSIS immediately shut down the establishment, and it was only 
allowed to re-open under a new name and different ownership after 
reaching an agreement with FSIS that its facilities would be audited by 
an outside firm on a regular basis, and that employees would receive 
special training on humane handling of animals. In addition, Secretary 
of Agriculture Thomas Vilsack requested that the USDA's Office of 
Inspector General conduct a criminal investigation. While no Federal 
charges were filed, two establishment officials were criminally 
prosecuted by the State of Vermont.
    After reviewing the findings of the FSIS investigation and the 
issues raised in the petition, the Agency tentatively granted the HSUS 
petition but determined it would be useful to solicit public input on 
the issues raised in the petition before making a final decision. On 
February 7, 2011, FSIS published a document in the Federal Register 
requesting public comments on the HSUS petition (76 FR 6572). FSIS 
received approximately 74,200 comments in response to the Federal 
Register document (see 80 FR 27269 for a more detailed discussion of 
the comments and FSIS's responses). On March 13, 2013, FSIS granted the 
HSUS petition and announced that the Agency would begin rulemaking when 
resources allowed.
    In January 2014, FSIS conducted another investigation based on 
video footage captured by an HSUS undercover investigation at a second 
veal slaughter establishment. This video footage showed two humane 
handling violations committed by the establishment, including an 
employee dragging and rolling a non-ambulatory disabled veal calf into 
a holding pen. The subsequent FSIS investigation found that, while the 
establishment had a comprehensive systematic approach to its humane 
handling program, the establishment failed to implement effective 
humane handling methods, resulting in egregious violations (see 80 FR 
27270 for more details on the investigation).
    As explained in the proposed rule, published May 13, 2015, 
prohibiting the slaughter of all non-ambulatory veal calves will 
improve compliance with the HMSA and the humane slaughter implementing 
regulations (80 FR 27269). FSIS's 2009 and 2014 investigations of 
incidents of inhumane handling at official veal slaughter 
establishments demonstrate that the set-aside provision may create an 
incentive for establishments to inhumanely force non-ambulatory 
disabled veal calves to rise. The set-aside provision may also provide 
an incentive for livestock producers and establishments to send 
weakened veal calves to slaughter in the hope that the veal calves are 
able to sufficiently recover in time to pass ante-mortem inspection. 
Sending such weakened veal calves to slaughter increases the chances 
that they will go down and be subjected to conditions that are inhumane 
(80 FR 27271). In addition, FSIS inspectors may not always be able to 
distinguish between a veal calf that is non-ambulatory disabled because 
it is tired or cold from a veal calf that is injured or sick. Thus, 
allowing re-inspection may encourage establishments to hold ill or 
injured veal calves in an attempt to allow them to recover and pass re-
inspection before collapsing.
    FSIS is also concerned about the treatment of veal calves during 
extended hold times. For example, non-compliance records (NRs) from 
2012 to 2015 included 33 instances of failing to provide veal calves 
with access to water.
    Finally, removing the set-aside provision will also improve the 
Agency's inspection efficiency by eliminating the time that FSIS 
inspectors spend re-inspecting non-ambulatory disabled veal calves.

Final Rule

    After consideration of all of the comments, FSIS is finalizing the 
provisions of the May 13, 2015 proposed rule with one change. The final 
rule removes a provision in the Federal meat inspection regulations 
that requires all ante-mortem inspections to be conducted in pens (9 
CFR 309.1(b)).
    Comments discussed below submitted in response to the proposed rule 
showed confusion about exactly when animals are ``offered for 
slaughter,'' and when inspectors may conduct ante-mortem inspection. 
Some commenters stated that establishments could exploit a loophole in 
the regulations by setting aside non-ambulatory disabled veal calves to 
rest and recover, and offer the calves for ante-mortem inspection at a 
later time.
    Currently, FSIS inspectors are instructed to conduct ante-mortem 
inspection on transportation vehicles if the animals cannot be unloaded 
for any reason (see FSIS Directive 6,900.2, Humane Handling and 
Slaughter of Livestock). To harmonize the regulations with this 
established policy, FSIS is amending the regulations by removing a 
provision in 9 CFR 309.1(b) that requires ante-mortem inspection to be 
performed ``in pens''.
    FSIS is amending these regulations under 21 U.S.C. 621, which gives 
FSIS the authority to adopt regulations for the efficient 
administration of the Federal Meat Inspection Act (FMIA). The 
amendments in this rule are intended to facilitate more effective 
implementation of ante-mortem inspection pursuant to 21 U.S.C. 603(a) 
and of the humane handling requirements established pursuant to 21 
U.S.C. 603(b).

Comments and Responses

    FSIS received approximately 42,054 comments from animal welfare 
write-in campaigns that supported the proposed rule. FSIS also received 
35 comments from animal welfare organizations, members of Congress, and 
private citizens that also supported the proposed rule. FSIS received 
approximately 20 comments from organizations representing meat 
processors, cattle producers, dairy producers, farm bureaus, and 
private citizens that opposed the proposed rule.
    Comment: Several farm bureaus stated that the current regulations 
adequately protect non-ambulatory disabled veal calves from inhumane 
treatment. These commenters noted that FSIS has trained personnel in 
establishments at all times to ensure that calves are humanely handled, 
and veal producers have too big of a financial incentive to violate the 
HMSA.

[[Page 46572]]

    Response: FSIS is amending the regulations to improve compliance 
with the HMSA and improve the Agency's inspection efficiency by 
eliminating the time that FSIS inspectors spend re-inspecting non-
ambulatory disabled veal calves.
    As explained in the Background section, FSIS conducted 
investigations in 2009 and 2014 in response to undercover videos taken 
by HSUS that showed establishments using force to get non-ambulatory 
disabled veal calves to rise for inspection. Based on the findings of 
these investigations, FSIS concluded that the set-aside provision may 
create an incentive for establishments to inhumanely force non-
ambulatory disabled veal calves to rise.
    Furthermore, the 2014 HSUS video showed that humane handling 
violations can occur outside the view of FSIS inspectors. FSIS 
inspectors are unable to continuously monitor non-ambulatory veal 
calves that have been set apart to warm and rest because they must 
perform other food safety inspection-related activities between the 
time that the calves are set apart and the time of inspection after the 
resting period.
    Comment: An industry trade association and veal processor stated 
that condemnation and prompt disposal of non-ambulatory disabled veal 
calves would waste potentially healthy animals that can go into the 
food supply.
    Response: The carcasses, parts thereof, meat, or meat food products 
of non-ambulatory disabled veal calves will be considered unfit for 
human food and thus adulterated pursuant to 21 U.S.C. 601(m)(3). 
However, the carcasses of condemned veal calves may have other, 
inedible-product, uses (e.g., through rendering).
    In addition, the estimated cost of the final rule will have a 
minimal financial impact on the veal industry. Market value estimates 
for slaughtered veal calves based on CY2015 data reported by the U.S. 
Department of Agriculture, Agricultural Marketing Service (AMS), were 
between $264.0 million and $435.8 million. The expected first-year 
total cost estimate to the U.S. veal industry that would be associated 
with this rule ranges between $0.374 million and $1.206 million. Thus, 
the value lost to the U.S. veal industry ranges between 0.14% and 0.28% 
of the total veal value in a year.
    The minimal financial impact to the U.S. veal industry is 
outweighed by the benefits cited in this rule, including increased 
compliance with the HMSA and improved inspection efficiency. FSIS 
predicts that this rule will save the Agency between 180 inspection 
hours (minimum) and 297 inspection hours (maximum) in total each year. 
The saved inspection time will allow FSIS personnel to conduct other 
inspection activities.
    Comment: One veal processor stated that the formula fed veal 
industry has voluntarily undertaken measures in the past eight years to 
improve conditions for the production and care of veal calves, 
rendering moot some of the reasons cited for the rule.
    Response: FSIS's investigations in 2009 and 2014 and non-compliance 
records from 2012 to 2015 demonstrate that voluntary measures 
undertaken by the industry have not adequately prevented the inhumane 
treatment of non-ambulatory disabled veal calves. Specifically, FSIS 
has determined that establishments may have an incentive to force non-
ambulatory disabled veal calves that have been set aside pursuant to 9 
CFR 309.13(b) to rise. Therefore, the Agency has determined that a 
change in the regulations is needed to remove the set-aside provision 
and ensure compliance with humane handling requirements at official 
establishments.
    Comment: Several industry trade associations stated that FSIS's 
2009 and 2014 investigations in response to HSUS' undercover video 
footage did not present evidence of a systemic problem of inhumane 
handling of non-ambulatory disabled veal calves. These commenters 
stated that FSIS has identified only two incidents of inhumane handling 
of non-ambulatory disabled veal calves in the 37 years it has enforced 
the HMSA. In addition, the commenters stated that only two out of 364 
suspension actions taken by the Agency in the six-year window involve 
establishment employees forcing non-ambulatory disabled veal calves to 
rise.
    The same commenters also stated that the lack of non-compliance 
records (NRs) citing non-ambulatory disabled veal calves suggests the 
calves are treated with care. These commenters noted that the NRs cited 
in the proposed rule do not record establishment personnel forcing non-
ambulatory disabled veal calves to rise.
    A beef producer advocacy group questioned whether FSIS has 
sufficient scientific evidence or expert testimony to support the 
Agency's claim that setting aside downed veal calves results in 
inhumane treatment. The comment also stated that FSIS failed to perform 
a comprehensive review of the peer-reviewed scientific literature or 
research regarding factors that lead to downed veal calves.
    Response: FSIS disagrees that the number of suspension actions and 
NRs indicates that a change in the regulations is unnecessary. FSIS 
proceeded with this rulemaking after conducting a thorough review of 
the 2009 and 2014 investigations, NRs, peer-reviewed scientific 
literature, and public comments, as well as consulting with Agency 
subject-matter experts and staff in the field. FSIS concluded that the 
totality of evidence showed that, under current regulations, 
establishments may have a financial incentive to force non-ambulatory 
disabled calves to rise from a recumbent position and send weakened 
veal calves to slaughter. Thus, a change in the regulations is 
necessary to comply with the HMSA and its implementing regulations.
    FSIS convened an intra-agency workgroup composed of subject-matter 
experts to assist with this rulemaking. In addition, the Agency 
consulted with the FSIS Office of Field Operations to collect data for 
establishments that slaughter veal calves in order to accurately 
determine the number of non-ambulatory disabled veal calves that were 
inspected after the recovery time and then sent for slaughter.
    In the proposed rule, FSIS cited 33 NRs between 2012 and 2014 to 
support these conclusions. In addition, the Agency has conducted a 
review of NRs issued in 2015. In 2015, the Agency found one instance of 
excessive use of an electric prod in an attempt to force a non-
ambulatory disabled veal calf to rise, one instance of ambulatory veal 
calves walking over a non-ambulatory veal calf, three instances of veal 
calves in holding pens without water, and one instance of veal calves 
in a holding pen for longer than 24 hours without feed. These findings 
reinforce the Agency's conclusions that establishments may have an 
incentive to force veal calves to rise and send weakened calves to 
slaughter. In addition, as was demonstrated in the 2014 HSUS video, 
FSIS believes that many of these occurrences happen outside the view of 
inspection personnel.
    FSIS also conducted a thorough review of relevant peer-reviewed 
scientific literature, including peer-reviewed literature cited in the 
petition submitted by HSUS, regarding factors that can lead to non-
ambulatory disabled veal calves. Based on its findings, the Agency 
concluded that there is a direct correlation between the growing and 
transport conditions of veal calves, and whether these calves arrive at 
an establishment non-ambulatory

[[Page 46573]]

disabled.\2\ Thus, the Agency estimates that by incentivizing growers 
and transporters to improve animal welfare conditions, this final rule 
will lead to stronger, healthier calves being offered for slaughter.\3\
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    \2\ Gonz[aacute]lez, L.A., Schwartzkopf-Genswein, K.S., Bryan, 
M., Silasi, R., and Brown F. (2015). ``Relationship between 
transport conditions and welfare outcomes during commercial long 
haul transport of cattle in North America''. American Society of 
Animal Science, 90(10):3640-51 doi: 10.2527/jas2011-4796.
    \3\ Trunkfield, H.R., and Broom, D.M. (1990). ``The Welfare of 
Calves During Handling and Transport''. Applied Animal Behaviour 
Science, v. 28, p. 135-152.
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    Comment: Several farm bureaus stated that complete elimination of 
non-ambulatory disabled veal calves from animals intended for slaughter 
for human food is an unrealistic goal. These commenters, along with 
industry trade groups and a veal processor, noted that otherwise 
healthy calves could be non-ambulatory disabled for a myriad of 
reasons, including the age and size of calves, adverse weather 
conditions, transportation time, calf hydration status, and length of 
time between unloading and stunning process.
    Response: The Agency acknowledges that many circumstances may 
contribute to calves arriving at establishments in a non-ambulatory 
disabled condition. However, FSIS's current regulations may provide an 
incentive for livestock producers and establishments to send weakened 
veal calves to slaughter in the hope that the veal calves are able to 
sufficiently recover to pass ante-mortem inspection. Sending such 
weakened veal calves to slaughter increases the chances that they will 
go down and be subjected to conditions that are inhumane. In addition, 
a study conducted by researchers from the University of Manitoba 
Department of Animal Science, and Agriculture and Agri-Food Canada's 
Lethbridge Research Centre indicated that there is a direct correlation 
between calves that arrive at an establishment non-ambulatory disabled 
and poor animal welfare conditions before and during transport.\4\ The 
study indicated that animal condition upon loading is an important risk 
factor in the outcome of the journey.
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    \4\ Gonz[aacute]lez, L.A., Schwartzkopf-Genswein, K.S., Bryan, 
M., Silasi, R., and Brown F. (2015). ``Relationship between 
transport conditions and welfare outcomes during commercial long 
haul transport of cattle in North America''. American Society of 
Animal Science, 90(10):3640-51 doi: 10.2527/jas2011-4796.
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    This final rule will not lead to a complete elimination of non-
ambulatory disabled veal calves that arrive at slaughter 
establishments; however, it will likely create an incentive for growers 
and transporters to improve animal welfare conditions and send 
healthier and stronger animals that can handle the stress and other 
risk factors associated with transportation to slaughter 
establishments. This will, in turn, reduce the number of non-ambulatory 
disabled veal calves that arrive at establishments.
    Comment: One veal processor stated that the proposed rule should 
apply only to bob veal calves and should exclude formula fed and non-
formula fed veal calves. The same commenter stated that the growing 
conditions of formula fed veal calves, including vaccinations, iron 
rich diets, and group loose-housing pens, make formula fed veal calves 
less susceptible to diseases than bob veal calves.
    Response: The final rule will apply to all non-ambulatory disabled 
veal calves and does not distinguish bob veal calves from formula and 
non-formula fed veal calves. Although the Agency acknowledges that 
formula fed veal calves are typically stronger and less susceptible to 
disease than bob veal calves, and the Agency's regulatory impact 
analysis reveals that a higher percentage of bob veal calves will most 
likely be affected by this final rule, FSIS's 2014 investigation showed 
that humane handling violations do occur at formula fed veal calf 
slaughter establishments.
    Comment: A private citizen recommended that the rule distinguish 
between fatigued versus diseased animals to prevent the waste of 
otherwise healthy animals. An industry trade association, a veal 
processor, and a doctor of veterinary medicine questioned FSIS's 
assertion that prohibiting the slaughter of all non-ambulatory disabled 
veal calves will eliminate uncertainty in determining the disposition 
of these calves. These commenters stated that inspectors are capable of 
determining whether a calf is diseased or injured rather than tired or 
cold.
    Response: In 2009, FSIS amended 9 CFR 309.3(e) to remove the case-
by-case disposition determination of cattle that became non-ambulatory 
disabled after ante-mortem inspection in order to reduce the 
uncertainty in determining the proper disposition of these cattle and 
increase FSIS inspector efficiency (74 FR 11463). FSIS has used the 
same rationale here.
    This final rule eliminates the time that FSIS inspectors spend 
determining whether veal calves are non-ambulatory disabled because 
they are tired or cold or because they have diseases, such as enteritis 
(80 FR 27270). This final rule also eliminates the time that FSIS 
inspectors spend inspecting the veal calves that were set apart.
    Comment: Two animal welfare groups and an individual noted that 
FSIS requires non-ambulatory disabled adult cattle to be condemned and 
disposed of, and requested that FSIS extend the same requirement to 
non-ambulatory disabled veal calves. In contrast, two farm bureau 
organizations stated that non-ambulatory disabled veal calves should 
not be treated the same as adult cattle, noting that veal calves are 
not a risk for bovine spongiform encephalopathy (BSE), and do not pose 
the same food safety concerns as adult cattle.
    Response: FSIS issued a final rule in 2007 that prohibited the 
slaughter of non-ambulatory disabled cattle because of the threat of 
BSE, but created an exception for non-ambulatory disabled veal calves 
to be set apart and re-inspected. As explained in the proposed rule, 
while cattle younger than 30 months do not present a serious risk of 
BSE, they are susceptible to other systemic and metabolic diseases,\5\ 
and injury because of inadequate immunoglobulin transfer, nutritional 
inadequacies of an all-liquid iron deficient diet, activity 
restriction, and stress (80 FR 27270). As is discussed above, the 
Agency has also concluded that the set-aside provision implemented in 
2007 should nonetheless be removed because it may have created an 
incentive for establishments to inhumanely force non-ambulatory 
disabled veal calves to rise from a recumbent position. In addition, 
this final rule will increase inspection efficiency by eliminating the 
time that FSIS inspectors spend re-inspecting non-ambulatory disabled 
veal calves if they are again offered for slaughter.
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    \5\ McDonough, Sean P., Stull, Carolyn L., and Osburn, Bennie I. 
(1994). ``Enteric Pathogens in Intensively Reared Veal Calves''. 
American Journal of Veterinary Research, v. 55, no. 11, p. 1516-
1519.
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    Comment: Several animal welfare groups requested that FSIS clarify 
when livestock are ``offered'' for slaughter. These commenters stated 
that establishments could exploit a loophole by setting aside non-
ambulatory disabled veal calves to rest and recover, and ``offer'' the 
calves for ante-mortem inspection at a later time. One animal welfare 
group stated that animals should be considered ``offered'' for 
slaughter upon delivery at the slaughter establishment, following the 
same interpretation as when humane regulations apply per FSIS Directive 
6900.2, Ch. II(I) (rev. August 15, 2011).
    Response: FSIS has already explained to inspectors when animals 
destined for

[[Page 46574]]

slaughter are subject to humane handling regulations and FSIS 
inspections in FSIS Directive 6,900.2, Humane Handling and Slaughter of 
Livestock. The Directive states that once a vehicle carrying livestock 
enters, or is in line to enter, an official establishment's premises, 
the vehicle is considered to be a part of the establishment's premises, 
and the animals within the vehicle are to be handled in accordance with 
humane handling regulations. The Directive states that FSIS inspectors 
can conduct ante-mortem inspections at the vehicle. This Directive is 
in accord with the final rule that implements the HMSA (44 FR 68809; 
November 30, 1979), which states in the preamble that ``the Department 
intends to enforce the Act with regard to any inhumane activity 
occurring on the premises of an official establishment.''
    In addition, in the final rule FSIS is removing a provision in 9 
CFR 309.1(b) that requires ante-mortem inspection to be made ``in 
pens.'' This amendment harmonizes the regulations with current 
practice, and closes the potential loophole that may have allowed 
establishments to set aside non-ambulatory disabled veal calves to rest 
and recover, and ``offer'' them for slaughter at a later time. It also 
prevents establishments and transporters from diverting non-ambulatory 
disabled animals to other establishments. FSIS will update FSIS 
Directive 6,100.1, Ante-Mortem Livestock Inspection, to reflect this 
change. Inspectors have the option to perform the humane handling 
portion of ante-mortem inspection directly on the truck, and wait to 
complete ante-mortem inspection once the animals are in holding pens.
    FSIS inspectors may not be present in the early morning hours when 
animals typically arrive and are offloaded. FSIS may assign additional 
personnel to the establishment during off-hours to monitor the arrival 
of the animals if FSIS identifies the need to do so.
    Comment: Two animal welfare organizations and a food safety 
organization stated that the definition given for ``promptly'' in the 
preamble to the proposed rule is too vague and gives too much 
discretion to establishments. One animal welfare organization asked 
FSIS to explain the ``facts and circumstances'' to be taken into 
account by inspectors and establishment employees when an animal is 
found to be non-ambulatory disabled.
    Response: The Agency disagrees that it gave too much discretion to 
establishments. As FSIS explained in the proposed rule, all condemned 
non-ambulatory disabled cattle must be euthanized within a reasonable 
time in view of all of the facts and circumstances (80 FR 27271). The 
facts and circumstances that FSIS inspectors will take into account 
when assessing compliance with the ``promptly'' requirement include 
whether the animal is suffering (e.g., injured, dehydrated, or 
vulnerable to being stepped on by ambulatory cattle), and extenuating 
circumstances such as weather conditions and emergencies.
    Comment: One food safety organization requested that FSIS consider 
prohibiting the slaughter of other farm animals that can be susceptible 
to ``downer'' illnesses, including swine, sheep, and goats.
    Response: The proposed rule and request for comments addressed the 
disposition of non-ambulatory disabled veal calves only. In 2013, FSIS 
denied a petition submitted on behalf of Farm Sanctuary that requested 
the Agency to amend its ante-mortem inspection regulations to require 
non-ambulatory disabled pigs, sheep, goats, and other amenable 
livestock species to be condemned. In 2014, FSIS received another 
petition on behalf of Farm Sanctuary and various other animal advocacy 
organizations that requested the Agency to amend its ante-mortem 
inspection regulations to prohibit the slaughter of non-ambulatory 
disabled pigs. FSIS will conduct a full independent review and analysis 
of this petition to determine the validity of the requested rulemaking.
    Comment: Several industry members stated that the annual economic 
impact of the proposed regulatory changes will be significantly higher 
on the veal industry than portrayed in the proposed rule. These 
commenters stated that the veal industry had much higher production 
costs in 2015 than in previous years.
    An industry trade association and veal processor also questioned 
FSIS's use of deleted records in the Agency's Public Health Information 
System (PHIS) to determine the number of non-ambulatory disabled veal 
calves that are currently re-inspected and released for slaughter. 
These commenters stated that the use of deleted records in PHIS is not 
a close approximation of the actual number of non-ambulatory disabled 
veal calves released for slaughter in veal establishments.
    Response: FSIS updated its cost estimate to reflect 2015 prices. 
The estimated market value of bob veal increased to $20.00-$560.00 per 
head in 2015, while the market value of formula and non-formula fed 
veal increased to $1,000.00-$1,300.00 per head in 2015.\6\
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    \6\ Data derived from USDA/AMS Weekly Veal Market Summary, Vol 
18, Numbers 1-41. At: http://www.ams.usda.gov/mnreports/lswveal.pdf.
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    FSIS also changed its methodology for determining the number of 
non-ambulatory disabled veal calves that were inspected after the 
recovery time and then sent for slaughter. FSIS collected additional 
data via the FSIS Office of Field Operations for the establishments 
that slaughter veal calves, and estimated the number of non-ambulatory 
disabled veal calves based on this data. As a result, FSIS adjusted its 
estimated number of non-ambulatory disabled veal calves for all three 
veal categories.
    On the basis of these updated numbers, FSIS adjusted its estimated 
annual cost for the final rule. The new estimated annual cost to the 
U.S. veal industry ranges between $0.374 million and $1.206 million 
compared to $0.002 million and $0.161 million in the proposed rule.
    Comment: Several farm bureaus asked if the proposed rule will 
improve the efficiency of the inspection process. These commenters 
stated that calves are often rested in the same unloading area where 
the inspectors work, and inspection of recovered calves only amounts to 
a minor inconvenience and takes up little of the inspectors' time.
    Response: FSIS has conducted an analysis of PHIS data, and has 
determined that it takes an inspector approximately 15 minutes to 
inspect a calf after recovery. Because FSIS will no longer have to 
inspect non-ambulatory disabled veal calves to determine their 
disposition, the Agency will save between 180 hours (minimum) and 297 
hours (maximum) in total. This time will allow inspectors the ability 
to engage in other inspection activities.

Executive Orders 12866 and 13563, and the Regulatory Flexibility Act

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This final rule has been designated a ``non-significant'' 
regulatory action under section 3(f) of Executive Order (E.O.) 12866.

[[Page 46575]]

Accordingly, the rule has not been reviewed by the Office of Management 
and Budget under E.O. 12866.

Baseline

    FSIS has updated the baseline for the final regulatory impact 
analysis (FRIA) to reflect the most recent available data. Table 1 
compares the total veal calves slaughtered in calendar year (CY) 2015 
(FRIA), CY2014, and CY2013 (preliminary regulatory impact analysis 
(PRIA)).

 Table 1--Total Veal Calves Inspected and Slaughtered CY2013 (Proposed Rule) vs. CY2014 vs. CY2015 (Final Rule)
----------------------------------------------------------------------------------------------------------------
                                                                               Sum of the head count
                                                                 -----------------------------------------------
                         Veal calf type                               CY2013          CY2014          CY2015
                                                                      (1,000)         (1,000)         (1,000)
----------------------------------------------------------------------------------------------------------------
Bob Veal........................................................           405.6           248.3           173.6
Formula Fed Veal................................................           310.8           282.8           253.8
Non-Formula Fed Veal............................................             8.6             7.4             6.7
                                                                 -----------------------------------------------
    Total.......................................................           725.5           538.5           434.1
----------------------------------------------------------------------------------------------------------------
Source: FSIS, Public Health Information System (PHIS)

    In CY2015, federally-inspected veal calf establishments slaughtered 
a total of 434,051 veal calves (Table 2). Market value estimates for 
slaughtered veal calves based on CY2015 data reported by the U.S. 
Department of Agriculture, Agricultural Marketing Service (AMS), were 
between $264.0 million and $435.9 million.\7\ FSIS used the minimum and 
maximum veal calf prices reported by USDA/AMS. These prices were 
$20.00-$560.00 for bob veal and $1,000.00-$1,300.00 for formula fed and 
non-formula fed veal calves.
---------------------------------------------------------------------------

    \7\ Bob Veal Market Value: $20.00-$560.00 per head. Formula and 
non-formula fed veal market value: $1,000.00-$1,300.00 per head. 
Data derived from USDA/AMS Weekly Veal Market Summary, Vol 18, 
Numbers 1-41. At: http://www.ams.usda.gov/mnreports/lswveal.pdf.

                 Table 2--Total Veal Calves Inspected and Slaughtered and Market Value, CY 2015
----------------------------------------------------------------------------------------------------------------
                                                                                    Min market      Max market
                         Veal calf type                             Sum of head       value *         value *
                                                                  count  (1,000)   ($1,000,000)    ($1,000,000)
----------------------------------------------------------------------------------------------------------------
Bob Veal........................................................           173.6            $3.5           $97.2
Formula Fed Veal................................................           253.8           253.8           329.9
Non Formula Fed Veal............................................             6.7             6.7             8.7
                                                                 -----------------------------------------------
    Grand Total *...............................................           434.1           264.0           435.9
----------------------------------------------------------------------------------------------------------------
Notes: Head Slaughtered source--FSIS, Public Health Information System (PHIS).
* Sum may not add up due to rounding.

    The U.S. veal industry is made up of establishments in the small 
and very small Hazard Analysis and Critical Control Point (HACCP)-size 
categories.\8\ In CY 2015, there were 118 federally inspected and nine 
state inspected establishments that slaughtered veal calves. Of the 118 
federally inspected establishments, 90 (76%) were very small, and 28 
(24%) were small HACCP size establishments.
---------------------------------------------------------------------------

    \8\ HACCP size: Very Small Establishment = Less than 10 
employees or less than $2.5 million in annual sales; Small 
Establishment = 10-499 employees; Large Establishment = 500 or more 
employees.
---------------------------------------------------------------------------

Expected Cost of the Final Rule

    The expected costs of the final rule for the veal establishments 
are a result of the lost market value of the non-ambulatory disabled 
veal calves that the affected establishments will no longer be able to 
slaughter for human food. The addition of the word ``promptly'' to 9 
CFR 309.3(e) does not have any expected costs, nor does the removal of 
the requirement that ante-mortem inspection be conducted ``in pens'' (9 
CFR 309.1(b)).
    FSIS collected additional data via the FSIS Office of Field 
Operations for the establishments that slaughter veal calves. As a 
result, FSIS adjusted its estimated annual cost for the FRIA based on 
new calculated non-ambulatory disabled veal ratios and the 2015 prices.
    In CY 2015, there were eight establishments that accounted for 
99.96% of the formula fed veal calves slaughtered in the U.S. Taking 
into account that extreme weather conditions and transit fatigue during 
the winter and summer months can affect the number of non-ambulatory 
disabled veal calves, FSIS recalculated its cost estimates, using the 
2015 prices.

                                                Table 3--Total Veal Calves Slaughtered and Market Value *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Minimum         Maximum
                                            Sum of the     Min number of   Max number of      Minimum         Maximum      market value    market value
             Veal calf type                 head count       NAD veal        NAD veal      market value    market value        lost            lost
                                              (1,000)                                       ($million)      ($million)      ($million)      ($million)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bob Veal................................           173.6             352             455            $3.5           $97.2          $0.007          $0.255
Formula Fed Veal........................           253.8             358             713           253.8           329.9           0.358           0.927

[[Page 46576]]

 
Non Formula Fed Veal....................             6.7               9              19             6.7             8.7           0.009           0.024
                                         ---------------------------------------------------------------------------------------------------------------
    Grand Total.........................           434.1             720           1,187           264.0           435.9           0.374           1.206
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The values are based on 2015 prices. The slaughter head counts are based on CY 2015 PHIS data.

    Based on the new data, FSIS adjusted the maximum number of formula 
fed veal calves that might be condemned due to this rule upward to 713 
(253,837 * 0.00281), with an estimated maximum cost of $0.927 million. 
The minimum number of formula fed veal calves that might be condemned 
due to this rule is 358 (253,837 * 0.00141), with an estimated minimum 
cost of $0.358 million.
    FSIS also adjusted the maximum number of bob veal and non-formula 
fed veal calves. For the bob veal, five establishments accounted for 
83% of the total bob veal calves slaughtered in the United States. The 
maximum number of bob veal calves affected by the final rule was 
adjusted to 455 (173,556 * 0.00262), with an estimated maximum cost of 
$0.255 million. The minimum number of bob veal calves that might be 
condemned due to this rule is 352 (173,556 * 0.00203), with an 
estimated minimum cost of $0.358 million.
    For non-formula fed veal calves, FSIS assumed the same non-
ambulatory disabled rates as for the formula fed veal calves. The 
maximum number of non-formula fed veal calves affected by the final 
rule was adjusted to 19 (6,658 * 0.00281), with an estimated maximum 
cost of $0.025 million. The minimum number of non-formula fed veal 
calves that might be condemned due to this rule is 9 (6,658 * 0.00141), 
with an estimated minimum cost of $0.009 million.
    As illustrated in table 2, the expected first year total costs to 
the U.S. veal industry due to the final rule ranges between $0.374 
million and $1.026 million. The estimated costs have a minimal impact 
on the veal industry. The value lost to the U.S. veal industry ranges 
between 0.14% and 0.28% of the total veal value in a year.

Expected Benefits of the Final Rule

    FSIS predicts that this rule would provide Agency personnel with 
savings in terms of inspection time. According to PHIS data, it takes 
an inspector approximately 15 minutes to re-inspect a calf. Because 
FSIS will not have to re-inspect the veal calves that are non-
ambulatory disabled, the Agency will save anywhere from 180 hours 
(minimum) to 297 hours (maximum) in total (table 4). The saved 
inspection time will allow the inspector the ability to engage in other 
inspection activities.

                                    Table 4--Benefit In Terms of Time Saving
----------------------------------------------------------------------------------------------------------------
                                                                    Formula fed     Non-formula
        Time to do ante-mortem inspection            Bob veal          veal          fed veal          Total
----------------------------------------------------------------------------------------------------------------
Minimum Number of Veal Calves Affected..........             352             358               9             719
Maximum Number of Veal Calves Affected..........             455             713              19           1,187
Minimum Time Saved..............................              88              89               2             180
Maximum Time Saved..............................             114             178               5             297
----------------------------------------------------------------------------------------------------------------
Source: PHIS.

    The final rule will ensure the humane disposition of the non-
ambulatory disabled veal calves. The rule will also increase the 
efficiency and effective implementation of inspection and humane 
handling requirements at official establishments. In addition, the rule 
will incentivize growers and transporters of cattle to improve animal 
welfare, both before and during transport.
    A recent study conducted by researchers from the University of 
Manitoba Department of Animal Science's Agriculture and Agri-Food 
Canada, Lethbridge Research Centre, shows that there is a correlation 
between transport and transport conditions such as temperature, length 
of the trip, and space allowance (density of animals to size), and 
cattle arriving at the establishment dead, lame, or non-ambulatory 
disabled. The study notes that, out of all classes of cattle, calves 
and cull cattle are ``more likely to be dead and non-ambulatory during 
the journey.'' The authors indicate that animal condition upon loading 
plays an important risk factor in the outcome of the journey. The study 
concludes that cattle arriving at an establishment dead, lame, or non-
ambulatory disabled is an indication of extremely poor welfare 
conditions.\9\ The final rule will therefore reduce the number of 
calves that arrive at establishments non-ambulatory disabled by 
incentivizing growers and transporters to improve animal welfare 
conditions and send healthier and stronger animals to slaughter 
establishments.
---------------------------------------------------------------------------

    \9\ Gonz[aacute]lez, L.A., Schwartzkopf-Genswein, K.S., Bryan, 
M., Silasi, R., and Brown F. (2015). ``Relationship between 
transport conditions and welfare outcomes during commercial long 
haul transport of cattle in North America''. American Society of 
Animal Science, 90(10):3640-51 doi: 10.2527/jas2011-4796.
---------------------------------------------------------------------------

Regulatory Flexibility Act Assessment

    The FSIS Administrator certifies that, for the purpose of the 
Regulatory Flexibility Act (5 U.S.C. 601-602), the final rule will not 
have a significant economic impact on a substantial number of small 
entities in the United States. The Agency estimates that this rule 
would possibly affect 127 (118 federally inspected) small and very 
small HACCP size veal slaughter establishments. Although many small and 
very small establishments are affected by this rule, the volume of veal 
that will not be eligible for slaughter is very low. Further, the 
estimated total annual cost per establishment is between $2,945 (total 
minimum cost/number of establishments = $374,000/127) and $8,087 (total 
maximum cost/number of establishments = $1,027,000/127).

[[Page 46577]]

Paperwork Reduction Act

    There are no paperwork or recordkeeping requirements associated 
with this final rule under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520).

E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things, 
promoting the use of the Internet and other information technologies 
and providing increased opportunities for citizen access to Government 
information and services, and for other purposes.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this rule: (1) All State and local laws and 
regulations that are inconsistent with this rule will be preempted; (2) 
no retroactive effect will be given to this rule; and (3) no 
administrative proceedings will be required before parties may file 
suit in court challenging this rule.

Executive Order 13175

    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, ``Consultation and Coordination with Indian 
Tribal Governments.'' E.O. 13175 requires Federal agencies to consult 
and coordinate with tribes on a government-to-government basis on 
policies that have tribal implications, including regulations, 
legislative comments or proposed legislation, and other policy 
statements or actions that have substantial direct effects on one or 
more Indian tribes, on the relationship between the Federal Government 
and Indian tribes or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.
    FSIS has assessed the impact of this rule on Indian tribes and 
determined that this rule does not, to our knowledge, have tribal 
implications that require tribal consultation under E.O. 13175. If a 
Tribe requests consultation, the Food Safety and Inspection Service 
will work with the Office of Tribal Relations to ensure meaningful 
consultation is provided where changes, additions and modifications 
identified herein are not expressly mandated by Congress.

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410, 
Fax: (202) 690-7442, Email: program.intake@usda.gov.
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS Web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of this publication available through 
the FSIS Constituent Update, which is used to provide information 
regarding FSIS policies, procedures, regulations, Federal Register 
notices, FSIS public meetings, and other types of information that 
could affect or would be of interest to our constituents and 
stakeholders. The Update is available on the FSIS Web page. Through the 
Web page, FSIS is able to provide information to a much broader, more 
diverse audience. In addition, FSIS offers an email subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

List of Subjects in 9 CFR Part 309

    Animal diseases, Meat inspection, Reporting and recordkeeping 
requirements.

    For the reasons set forth in the preamble, FSIS amends 9 CFR part 
309 as follows:

PART 309--ANTE-MORTEM INSPECTION

0
1. The authority citation for part 309 continues to read as follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.


0
2. Amend Sec.  309.1 by revising the heading and the first sentence of 
paragraph (b) to read as follows:


Sec.  309.1  Ante-mortem inspection on premises of official 
establishments.

* * * * *
    (b) Such ante-mortem inspection shall be made on the premises of 
the establishment at which the livestock are offered for slaughter 
before the livestock shall be allowed to enter into any department of 
the establishment where they are to be slaughtered or dressed or in 
which edible products are handled. * * *

0
3. Amend Sec.  309.3 by revising paragraph (e) to read as follows:


Sec.  309.3  Dead, dying, disabled, or diseased and similar livestock.

* * * * *
    (e) Establishment personnel must notify FSIS inspection personnel 
when cattle become non-ambulatory disabled after passing ante-mortem 
inspection. Non-ambulatory disabled cattle that are offered for 
slaughter must be condemned and promptly disposed of in accordance with 
Sec.  309.13.


Sec.  309.13  [Amended]

0
4. Amend Sec.  309.13(b) by removing the sentence ``Veal calves that 
are unable to rise from a recumbent position and walk because they are 
tired or cold may be set apart and held as provided in this 
paragraph.''

    Done in Washington, DC, on: July 11, 2016.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2016-16904 Filed 7-15-16; 8:45 am]
 BILLING CODE 3410-DM-P