[Federal Register: June 25, 2003 (Volume 68, Number 122)]
[Rules and Regulations]               
[Page 37730-37735]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn03-5]                         

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 320 and 381

[Docket No. 01-034N]

 
Need To Complete New Registration Form and Importance of 
Compliance With Recordkeeping and Registration Requirements Under the 
Federal Meat and Poultry Products Inspection Regulations

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Policy statement and request for comments.

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SUMMARY: Since 1970, FSIS has required registration by: Meat brokers; 
poultry products brokers; renderers; animal food manufacturers; 
wholesalers; warehousemen; and persons that engage in the business of 
buying, selling, transporting in commerce, or importing, any dead, 
dying, disabled, or diseased livestock (that is, cattle, sheep, swine, 
goats, horses, mules, or other equines) or poultry, or parts of the 
carcasses of livestock or poultry that have died otherwise than by 
slaughter. Also since 1970, FSIS has required these parties, all 
official establishments, and carriers and importers of poultry or 
livestock carcasses or parts or products of poultry or livestock 
carcasses to keep business records and to make such records available 
to FSIS employees upon request. Registration information and business 
records are critical in any FSIS investigation related to public 
health, food safety, or misbranding of meat or poultry products. For 
example, should Bovine Spongiform Encephalopathy (BSE), a neurogenetive 
disease in cattle, be introduced in the United States, registration 
information and business records will be crucial in tracing the source 
of BSE and in preventing its spread. FSIS intends to increase its 
enforcement of the registration and recordkeeping requirements to 
ensure that all businesses subject to the Federal Meat Inspection Act 
and Federal Poultry Products Inspection Act that are required to be 
registered with FSIS and/or to maintain business records are properly 
doing so.
    In this notice, FSIS is also informing the public that the Agency 
has developed a new registration form. Because this form requires that 
registrants provide certain information that was not required on the 
previous form, all parties required to register, including those that 
are currently registered, must complete the new form and submit it to 
FSIS. Parties must

[[Page 37731]]

submit the new registration form to FSIS by March 22, 2004.

DATES: Comments may be submitted by August 25, 2003. The new 
registration form will be available by December 22, 2003. All parties 
required to register with FSIS, including those currently registered, 
must complete the new registration form and submit it to FSIS by March 
22, 2004.

ADDRESSES: Submit one original and two copies of written comments to 
FSIS Docket Clerk, Docket No. 01-034N, U.S. Department of Agriculture, 
Food Safety and Inspection Service, Room 102, Cotton Annex, 300 12th 
Street, SW., Washington, DC 20250-3700. All comments submitted in 
response to this document will be available for public inspection in 
the Docket Clerk's office between 8:30 a.m. and 4:30 p.m., Monday 
through Friday. When the new registration form becomes available, 
parties can access the form over the Internet at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov/fsisforms/.
 To obtain a copy of the new registration 
form, parties may also write to USDA, FSIS, Program Evaluation, 
Enforcement and Review (PEER), Evaluation and Enforcement Division 
(EED), 300 West End Court Building, 1255 22nd Street NW., Room 300, 
Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Dr. Arshad Hussain, Division Director, 
Data Analysis and Statistical Support Staff, Food Safety and Inspection 
Service, U.S. Department of Agriculture (202) 720-3219.

SUPPLEMENTARY INFORMATION:

Recordkeeping Requirements

    In 1967, the Federal Meat Inspection Act (FMIA) was amended to add 
section 202 (21 U.S.C. 642), which requires that certain parties keep 
records that fully and correctly disclose all transactions involved in 
their businesses related to cattle, sheep, swine, goats, horses, mules, 
or other equines, their carcasses, parts or products of such animal 
carcasses for use as human or animal food. Similarly, in 1968, the 
Poultry Products Inspection Act (PPIA) was amended, including section 
11(b) (21 U.S.C. 460(b)), which requires that certain parties keep such 
records as are properly necessary for the effective enforcement of the 
PPIA, in order to protect the American consumer against adulterated or 
misbranded poultry and poultry products. These provisions of the FMIA 
and PPIA require that the following parties keep business records: Any 
persons, firms, or corporations that engage in the business of 
slaughtering any livestock (as enumerated above) or poultry, or 
preparing or processing, freezing, packaging, or labeling any 
carcasses, or parts or products of carcasses, of any such animals, for 
use as human food or animal food; any persons, firms, or corporations 
that engage in the business of buying or selling (as meat brokers or 
poultry products brokers, wholesalers, or otherwise), or transporting, 
or storing, or importing any livestock or poultry carcasses or parts or 
products of these carcasses; and any persons, firms, or corporations 
that engage in business as renderers, or engage in the business of 
buying, selling, or transporting, or importing any dead, dying, 
disabled, or diseased (referred to as 4-D) livestock or poultry or 
parts of the carcasses of such livestock or poultry that have died 
otherwise than by slaughter.
    In addition, those sections of the FMIA and PPIA require that, at 
all reasonable times, upon notice by a duly authorized representative 
of the Secretary of Agriculture (for example, an FSIS employee), these 
parties must afford the USDA representative access to their places of 
business and the opportunity to examine the facilities, inventory, and 
records and to copy all their records.
    Section 11(b) of the PPIA further requires that the businesses 
listed above which are subject to it retain such records for the period 
of time prescribed by the poultry products inspection regulations, not 
to exceed two years, unless otherwise directed by Secretary of 
Agriculture for good cause shown. Similarly, section 202 of the FMIA 
provides that required records must be maintained for the period of 
time prescribed by the meat inspection regulations.
    Regulations implementing these recordkeeping requirements were 
first published in 1970. The current regulations (9 CFR 320.1(b) and 
381.175(b)) list the types of records, including, among other records, 
the bills of sale, invoices, bills of lading, and receiving and 
shipping papers, that must be maintained; the types of transactions for 
which records must be maintained, including purchasing, selling, 
shipping, receiving, transporting, or otherwise handling any livestock, 
livestock carcass or part thereof, meat or meat food product, poultry, 
or poultry carcass or part or product thereof; and the information 
about the transaction that the records must include.
    Consistent with the provisions of the FMIA and the PPIA, Sec. Sec.  
320.4 and 381.178 of the FSIS' regulations provide that, upon 
presentation of official credentials by an FSIS employee (or any 
authorized USDA representative) during ordinary business hours, 
businesses that are required to maintain records must permit the FSIS 
employee to enter their place of business and examine and copy the 
records that are required to be kept pursuant to these regulations.
    Under sections 320.3 and 381.177 of the regulations, records 
required to be kept must be retained for at least two years after 
December 31 of the year in which the transaction to which they relate 
occurred. The regulations also require that records be retained for 
longer periods if the Administrator of FSIS requires their retention 
for purposes of any investigation or litigation under the FMIA or PPIA. 
In these situations, the Administrator is to provide written notice of 
a longer retention period to the person required to keep these records.
    Sections 320.2 and 381.176 of the regulations require that the 
parties that are required to maintain the records at the place they 
conduct business that is subject to the FMIA or PPIA, unless they 
conduct their business in multiple locations. If they conduct their 
business in multiple locations, businesses can maintain their records 
at their headquarters' office. When records are not in use, the 
regulations require that they be kept in a safe place at the required 
location.
    Section 11 (21 U.S.C. 1040) of the Egg Products Inspection Act 
requires that persons engaged in the business of transporting, 
shipping, or receiving any eggs or egg products in commerce or holding 
such articles so received, and all egg handlers, maintain records 
concerning their receipt, delivery, sale, movement, and disposition of 
all eggs and egg products handled by them. FSIS' implementing 
regulations are in 9 CFR 590.200. During its continuous inspection at 
official plants processing egg products, FSIS ensures that these plants 
comply with the recordkeeping requirements. FSIS is also responsible 
for enforcing the recordkeeping requirements for other businesses 
engaged in transporting, shipping, or receiving egg products in 
commerce or businesses engaged in holding these products. In this 
notice, FSIS is not focusing on egg products businesses because the 
recordkeeping requirements in the egg products inspection regulations 
are different from those in the meat and poultry products inspection 
regulations. In addition, unlike certain businesses subject to the FMIA 
and PPIA, egg products businesses are not required to register with 
FSIS. Furthermore, FSIS is developing a proposed rule on shell eggs and 
egg products that will

[[Page 37732]]

specifically address recordkeeping requirements.
    Congress passed the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (``the Bioterrorism Act'') (Pub. 
L. 107-188), which was signed into law on June 12, 2002. The 
Bioterrorism Act provides that the Secretary of Health and Human 
Services (HHS) may require the establishment and maintenance of records 
by persons who manufacture, process, pack, transport, distribute, 
receive hold, or import food for human or animal consumption in the 
United States. On May 9, 2003, the Food and Drug Administration (FDA) 
proposed regulations that would implement these recordkeeping 
requirements (68 FR 25188). The recordkeeping requirements that will 
apply under the Bioterrorism Act will not affect the recordkeeping 
requirements in FSIS'' regulations. Therefore, even after the 
Bioterrorism Act's recordkeeping requirements take effect, the 
recordkeeping requirements in FSIS'' regulations will continue to apply 
to the parties listed above.

Registration Requirements

    The FMIA and PPIA were also amended in 1967 and 1968, respectively, 
to add sections 203 (21 U.S.C. 643) and 11(c) (21 U.S.C. 460(c)). These 
provisions prohibit any person, firm, or corporation from engaging in 
commerce as a meat or poultry products broker, renderer, animal food 
manufacturer, wholesaler, or public warehouseman, or from buying, 
selling, or transporting, or importing any dead, dying, disabled or 
diseased livestock or poultry or parts of the carcasses of livestock or 
poultry that died otherwise than by slaughter unless they have 
registered their business as required by the regulations.
    Regulations implementing registration requirements were first 
published in 1970. Sections 320.5 and 381.179 of the current 
regulations require that the parties listed in the preceding paragraph 
register with FSIS, unless these parties conduct business only at an 
official establishment where meat or poultry inspection is maintained.
    According to the regulations, parties required to register with 
FSIS must do so by filing out a form and must provide current and 
correct information to FSIS, including their name, the address of all 
locations at which they conduct the businesses that require them to 
register, and all trade or business names under which they conduct 
these businesses.
    FSIS has developed a new registration form. In addition to 
requiring the name and addresses of locations at which registrants 
conduct business, the form requires that parties disclose the form of 
their organization (e.g., individually owned or partnership), the 
nature of their business (e.g., meat or meat products or poultry or 
poultry products), and the type of business they are engaged in (e.g., 
domestic broker, import broker, warehouseman, etc). The form also 
requires that registrants provide their phone number and e-mail address 
and the hours of operation of any of their subsidiaries, branches, or 
divisions that conduct the businesses that require them to register. 
According to the regulations, parties required to register with FSIS 
must do so within 90 days after they begin to engage in any of the 
businesses that require them to register.
    FSIS' new registration form will be available for use by December 
22, 2003. Because this form requires that registrants provide certain 
information that was not required on the previous form, including e-
mail address, phone number, and subsidiaries'' hours of operation, all 
parties required to register, including those that are currently 
registered, must complete the new form and submit it to FSIS. Parties 
must submit the form to FSIS by March 22, 2004.
    The registration form can be obtained over the Internet at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov/fsisforms/.
 To obtain the form, parties can also 
write to USDA, FSIS, Program Evaluation, Enforcement and Review (PEER), 
Evaluation and Enforcement Division (EED), 300 West End Court Building, 
1255 22nd Street, NW., Room 300, Washington, DC 20250-3700. The FSIS 
regulations provide a different mailing address for obtaining the 
registration form, and state that the registration form can be obtained 
from ``Compliance Programs, Regulatory Programs'' (Sec. Sec.  320.5(a) 
and 381.179(a)). FSIS intends to update this information in a future 
rule. The form will also be available from FSIS personnel that visit 
businesses required to register. Once parties complete the form, they 
should mail it to USDA, FSIS, Program Evaluation, Enforcement and 
Review (PEER), Evaluation and Enforcement Division (EED), 300 West End 
Court Building, 1255 22nd Street, NW., Room 300, Washington, DC 20250-
3700 (the same address as for obtaining forms) or fax it to Director, 
Evaluation and Enforcement Division (EED) at (202) 418-8941.
    The regulations require that, whenever any change is made in the 
registrant's name, business address, or any trade or business name 
under which it conducts its business, the registrant must report such 
change in writing to the Administrator within 15 days after making the 
change.
    The Bioterrorism Act includes a provision that requires the 
Secretary of HHS to develop regulations mandating domestic and foreign 
facilities that manufacture, process, pack or hold food for human or 
animal consumption in the United States to register with the FDA by 
December 12, 2003. On February 3, 2003, FDA proposed regulations that 
would implement these registration requirements (68 FR 5378). The 
registration requirements that will apply under the Bioterrorism Act 
will not replace the registration requirements in FSIS' regulations. 
Therefore, even after the Bioterrorism Act's registration requirements 
take effect, the registration requirements in FSIS' regulations will 
continue to apply to the parties listed above.

Bovine Spongiform Encephalopathy

    Bovine Spongiform Encephalopathy (BSE), commonly referred to as 
``Mad Cow Disease,'' is a slowly progressive degenerative disease that 
affects the central nervous system (CNS) of adult cattle. BSE belongs 
to the family of diseases known as the transmissible spongiform 
encephalopathies (TSEs). Other TSEs include scrapie in sheep and goats, 
transmissible mink encephalopathy, feline spongiform encephalopathy, 
chronic wasting disease (CWD) in deer and elk, and in humans, kuru, 
classic Creutzfeldt-Jakob Disease (CJD), Gerstmann-Straussler-Scheinker 
syndrome, fatal familial insomnia, and variant Creutzfeldt-Jakob 
Disease (vCJD).
    The agent that causes BSE and other TSEs has yet to be fully 
characterized. There are three main theories on the nature of the BSE 
agent: (1) The agent is a virus with unusual characteristics; (2) the 
agent is a prion--an abnormal form of a normal protein known as 
cellular prion protein; and (3) the agent is a virino--an 
``incomplete'' virus composed of nucleic acid protected by host 
proteins. The BSE agent is highly resistant to heat, ultraviolet light, 
ionizing radiation, and common disinfectants that normally inactivate 
viruses or bacteria. Scientific experts believe that prions most likely 
cause BSE and other TSEs.
    BSE was first diagnosed in 1986 in the United Kingdom (U.K.) and 
since then has been confirmed in native-born cattle in many other 
European countries and several countries outside Europe. This animal 
disease is most likely spread by feeding the rendered parts of cattle 
infected with the BSE agent to other cattle in the form of meat and 
bone meal. No cases of BSE have been

[[Page 37733]]

detected in the U.S. despite active surveillance for the disease since 
May 1990.
    In 1996, a newly recognized form of the human disease CJD, called 
variant CJD (vCJD), was reported in 10 patients in the U.K. vCJD is a 
chronic, neurodegenerative disease that affects humans. Scientific and 
epidemiological studies have linked vCJD to exposure to BSE, probably 
through human consumption of beef products contaminated with the agent 
that causes BSE.
    Until recently, vCJD had not been detected in the U.S. In April 
2002, the Florida Department of Health and the Centers for Disease 
Control and Prevention (CDC) began investigating a likely case of vCJD 
in a citizen of the U.K. living in Florida. In October 2002, CDC 
reported the investigation of this case and stated that it represents 
the first probable vCJD case in a U.S. resident (CDC, Morbidity and 
Mortality Weekly Report, 51(41): 927-929, 2002). CDC believes, however, 
that the patient was exposed to the BSE agent while living in the U.K. 
This is likely to be the case, as the disease is thought to have a long 
incubation period and the appearance of symptoms does not mean that 
exposure was recent.
    Surveillance data from European countries in which BSE has been 
detected indicate that cattle with clinical signs of a central nervous 
system (CNS) disorder, ``dead'' cattle (i.e., died otherwise than by 
slaughter), and cattle that cannot rise from a recumbent position 
(i.e., nonambulatory, cattle commonly referred to as ``downer'' cattle 
in the U.S.), have a greater incidence of having BSE than other cattle. 
The FSIS regulations prohibit for use as human food cattle with 
clinical signs of a CNS disorder or certain infectious or parasitic 
diseases, or that are in a dying condition or that died otherwise than 
by slaughter (Sec. Sec.  309.3, 309.4). All seriously crippled cattle 
and cattle commonly termed ``downers'' presented for slaughter are 
automatically suspected of being affected with a disease or condition 
that may require condemnation of the animal, in whole or in part, and 
are identified as ``U.S. Suspects'' (Sec.  309.2(b)). Such cattle are 
examined at ante-mortem inspection by an FSIS veterinarian, and a 
record of the veterinarian's clinical findings accompanies the carcass 
to post-mortem inspection if the animal is not condemned on ante-mortem 
inspection. Post-mortem inspections on the carcasses of U.S. Suspects 
cattle are performed by a veterinarian rather than a food inspector, 
and the results of this inspection are recorded. U.S. Suspects, unless 
otherwise released pursuant to Sec.  309.2(p), must be set apart and 
slaughtered separately (Sec.  309.2(n)). If, on post-mortem inspection, 
the meat and meat food products from such cattle are found to be 
otherwise not adulterated, such products may be used for human food 
(Sec.  311.1).
    Surveillance for BSE in Europe has shown that the typical clinical 
signs associated with BSE cannot always be observed in nonambulatory 
(downer) cattle infected with BSE because the signs of BSE often cannot 
be differentiated from the typical clinical signs of the many other 
diseases and conditions affecting downer cattle. Thus, if BSE were 
present in the U.S., it is possible that downer cattle infected with 
BSE could be presented for slaughter, and, if the clinical signs of the 
disease were not obvious, pass ante-mortem inspection. These cattle 
could then be slaughtered, and, if they pass post-mortem inspection, 
the meat and meat food products from such cattle could be used for 
human food. However, the BSE agent has not been detected in muscle 
tissue of infected cattle. Tissues that have been found to contain high 
levels of the agent that causes BSE in BSE-infected cattle--such as the 
brain tissue, the spinal cord, and the retina of the eye--could 
possibly cross-contaminate muscle tissues with the BSE agent during 
slaughter and processing.
    The U.S. government has implemented a number of measures to prevent 
BSE from entering the U.S. and to prevent the spread of the disease 
should it be introduced in the U.S. For example, since 1989, the USDA's 
Animal and Plant Health Inspection Service (APHIS) has prohibited the 
importation of live cattle and certain cattle products, including 
rendered protein products, from countries where BSE is known to exist. 
In 1997, because of concerns about widespread risk factors and 
inadequate surveillance for BSE in many European countries, these 
importation restrictions were extended to include all of the countries 
in Europe. On December 7, 2000, APHIS prohibited all imports of 
rendered animal protein products, regardless of species, from BSE-
restricted countries because of concern that feed intended for cattle 
may have been cross-contaminated with the BSE agent.
    In addition, APHIS leads an ongoing, comprehensive, interagency 
surveillance system for BSE in the U.S. and, in cooperation with FSIS, 
has drafted an emergency response plan to be used in the event that BSE 
is identified in the U.S. Other Federal agencies also have contingency 
plans that work in concert with the USDA plan.
    In 1997, the Food and Drug Administration (FDA) prohibited the use 
of most mammalian protein in the manufacture of animal feeds given to 
cattle and other ruminants (21 CFR 589.2000). Firms must keep specified 
records on the manufacture of their feed, must have processes in place 
to prohibit co-mingling of ruminant feed with non-ruminant feed, which 
may contain materials prohibited in ruminant feed, and must ensure that 
non-ruminant feed containing materials prohibited in ruminant feed is 
labeled conspicuously with the statement, ``Do not feed to cattle and 
other ruminants.'' These regulations are intended to prevent the 
introduction and spread of BSE in U.S. cattle through feed contaminated 
with the BSE agent.
    In addition, the CDC monitors the incidence of CJD in the U.S. by 
analyzing death certificate information from multiple-cause-of-death 
data compiled by the National Center for Health Statistics. This 
information is also used to search for possible cases of vCJD in the 
U.S.
    In 1998, USDA entered into a cooperative agreement with Harvard 
University's School of Public Health to conduct an analysis and 
evaluation of the current measures implemented by the U.S. government 
to prevent the entry and spread of BSE in U.S. cattle herds and to 
reduce the potential for exposure of Americans to the BSE agent. The 
Harvard study identifies three pathways or practices that could 
contribute the most to the spread of BSE and the amount of potentially 
dangerous tissue in the human food supply: (1) Noncompliance with the 
FDA feed ban, including misfeeding on the farm and the mislabeling of 
feed and feed products prohibited for consumption by cattle; (2) unsafe 
disposition of cattle that die on the farm; and (3) inclusion of high-
risk tissue, such as brain and spinal cord, in edible products. With 
regard to the second pathway listed, a potential use for cattle that 
die on the farm otherwise than by slaughter would be for rendering as 
non-ruminant animal feed since rendered product from animals that die 
otherwise than by slaughter is prohibited for use as human food but may 
be used to produce animal feed.
    On January 17, 2002, FSIS announced the availability of a paper on 
its current thinking on possible actions to minimize human exposure to 
meat products from cattle that could contain the infective agent that 
causes BSE (67 FR 2399). This paper is available on the

[[Page 37734]]

FSIS web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov/oa/topics/BSE_Thinking.pdf 
and http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov/oa/topics/BSE_thinking.htm.
    In this paper, FSIS stated that it planned to increase its 
enforcement of recordkeeping and registration requirements for 
renderers and persons who engage in the business of buying, selling, 
and transporting 4-D livestock or parts of the carcasses of any such 
livestock that died otherwise than by slaughter. In considering 
measures to minimize human exposure to bovine tissue and products that 
could contain the agent that causes BSE, FSIS determined that 
registration information and records from renderers and persons who 
engage in the business of buying, selling, and transporting 4-D 
livestock, or parts of the carcasses of any such livestock that died 
otherwise than by slaughter, would support FDA in enforcing its 
regulations that prohibit most mammalian protein in ruminant feed.
    Parts of carcasses of 4-D livestock are often used in rendering. 
Renderers produce meat and bonemeal and similar products used in 
livestock and poultry feed. If any ruminant feed is suspected of 
containing mammalian protein, FSIS will need and will be able to obtain 
registration information from the renderers that supplied rendered 
ruminant product to the animal feed manufacturers and from the 
producers or businesses that supplied the renderers with 4-D livestock 
or parts of carcasses of 4-D livestock. FSIS will also require and will 
have access to their related business records. FSIS will work 
collaboratively with FDA to locate these producers and businesses and 
obtain their records.
    Should BSE be introduced into the United States, registration 
information and business records will be crucial in quickly determining 
and tracking the source of BSE so as to prevent its spread. 
Registration information and business records would be crucial in 
tracking transactions involving cattle that are suspected of being, or 
confirmed to be, infected with BSE and carcasses and products that are 
suspected of being, or confirmed to be, contaminated with the agent 
that causes BSE.
    FSIS is reminding businesses subject to the PPIA that are required 
to register or maintain records that they must do so because the 
registration and recordkeeping requirements in the poultry products 
inspection regulations are almost identical to those in the meat 
inspection regulations. Also, FSIS needs to make sure that its 
information on registrants is accurate, complete, and current. 
Therefore, it is important that all businesses required to register 
under the FMIA or PPIA do so and keep their registrations current. As 
stated above, in this notice, FSIS is not focusing on egg products 
businesses because the recordkeeping requirements in the egg products 
inspection regulations are different from those in the meat and poultry 
products inspection regulations, because egg products businesses are 
not required to register with FSIS, and because FSIS is developing a 
proposed rule on shell eggs and egg products that will address 
recordkeeping requirements.

Failure To Register or Maintain Records

    As FSIS previously stated in its BSE current thinking paper, FSIS 
intends to increase enforcement of the registration and recordkeeping 
requirements discussed above. If FSIS determines that a party required 
to register, or a party required to maintain records, has not done so, 
FSIS program employees will first remind the party to register 
immediately or to maintain current and accurate records. If the party 
continues to violate the registration or recordkeeping requirements, 
FSIS will then issue a letter of warning. If any party continues to 
violate the registration or recordkeeping requirements after receiving 
a letter of warning, FSIS will consider pursuing criminal or other 
legal action against the violating party.
    For violations of the statute such as failure to register with FSIS 
or to maintain required records, section 406(a) of the FMIA (21 U.S.C. 
676(a)) provides that the penalties may be imprisonment for not more 
than one year, or a fine of not more than $1,000, or both such 
imprisonment and fine. The PPIA provides that the same penalties may be 
imposed for certain violations of the statute, including violation of 
registration and recordkeeping requirements (21 U.S.C. 461(a)). In 
addition, both statutes provide that if such violations involve intent 
to defraud, or any distribution or attempted distribution of an article 
that is adulterated (except when the product is adulterated for certain 
reasons, mostly concerning product quality), the penalty can be 
imprisonment for not more than three years or a fine of not more than 
$10,000, or both.
    Section 406(a) of the FMIA (21 U.S.C. 676(a)) also provides that 
persons, firms, or corporations would not be subject to the above 
penalties for receiving for transportation any article or animal in 
violation of the FMIA, if the receipt was made in good faith, unless 
the person, firm, or corporation refuses to furnish at the request of 
an FSIS employee the name and address of the person from whom it 
received such article or animal and copies of any documents pertaining 
to the delivery of the article or animal to them. Similarly, section 
12(b) of the PPIA (21 U.S.C. 461(b)) provides that carriers are not 
subject to penalties under the PPIA (except for violations of 
regulations concerning the buying, selling, or transporting of poultry 
carcasses or parts or products of poultry that are not intended for use 
as human food) for receiving, carrying, holding or delivering poultry 
or poultry products owned by another person, in carriers' usual course 
of business, unless they have knowledge or are in possession of facts 
that would indicate that the poultry or poultry products were not 
inspected or marked in accordance with the provisions of the PPIA or 
were otherwise not eligible for transportation under the PPIA. Carriers 
are liable, however, if they refuse to furnish at the request of an 
FSIS employee the name and address of the person from whom they 
received such poultry or poultry products, and copies of any documents 
pertaining to the delivery of the poultry or poultry products. These 
statutory provisions emphasize the importance of carriers' maintaining 
records of business transactions subject to the FMIA and PPIA and 
making these records available to FSIS employees.
    Under section 404 of the FMIA (21 U.S.C. 674) and section 21 of the 
PPIA (21 U.S.C. 467c), the United States district courts, the District 
Court of Guam, the District Court of the Virgin Islands, the highest 
court of American Samoa, and the United States courts of the other 
Territories, are vested with jurisdiction specifically to enforce, and 
to prevent and restrain violations of, the FMIA and PPIA (including 
violations of the registration and recordkeeping requirements).

Paperwork Reduction Act

    Title: Registration requirements under the FMIA and PPIA.
    Type of Collection: New.
    Abstract: FSIS has developed a new registration form and has 
reviewed the paperwork and recordkeeping requirements associated with 
this form in accordance with the Paperwork Reduction Act. Existing 
regulations require that certain parties register with FSIS. See 
``respondents'' below for a list of the parties required to register.
    According to the regulations, parties required to register with 
FSIS must do so by filing a form and must provide current and correct 
information to FSIS,

[[Page 37735]]

including their name, the address of all locations at which they 
conduct the businesses that require them to register, and all trade or 
business names under which they conduct these businesses. These parties 
must register with FSIS within 90 days after they begin to engage in 
any of the businesses that require them to register. Because FSIS has 
developed a new registration form that requires that registrants 
disclose certain information that was not required on the previous 
form, all parties required to register with FSIS, including those 
currently registered, must complete the new form and submit it to FSIS.
    Estimate of burden: FSIS estimates that completing the form will 
take an average of 10 minutes.
    Respondents: Meat brokers; poultry products brokers; renderers; 
animal food manufacturers; wholesalers; warehousemen; and persons that 
engage in the business of buying, selling, transporting in commerce, or 
importing, any dead, dying, disabled, or diseased livestock or poultry, 
or parts of the carcasses of livestock or poultry that have died 
otherwise than by slaughter.
    Estimated number of respondents: 9125 per year.
    Estimated number of responses per respondent: 1.
    Estimated total annual burden on respondents: 1,521 hours.
    Copies of this information collection assessment can be obtained 
from John OConnell, Paperwork Reduction Act Coordinator, Food Safety 
and Inspection Service, USDA, 112 Annex, 300 12th St., Washington, DC 
20250.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the Agency, including whether the information will have practical 
utility; (b) the accuracy of the Agency's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on those who 
are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology.
    Comments may be sent to John O'Connell, see address above, and the 
Desk Officer for Agriculture, Office of Information and Regulatory 
Affairs, Office of Management and Budget, Washington, DC 20253. 
Comments are requested by August 25, 2003. To be most effective, 
comments should be sent to OMB within 30 days of the publication date.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that 
minorities, women, and persons with disabilities are aware of this 
notice, FSIS will announce it and make copies of this Federal Register 
publication available in the FSIS Constituent Update, which is 
communicated via Listserv, a free e-mail subscription service. In 
addition, the update is available on-line through the FSIS web page 
located at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov. The update is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, recalls, and any other types of 
information that could affect or would be of interest to our 
constituents and stakeholders. The constituent Listserv consists of 
industry, trade, and farm groups, consumer interest groups, allied 
health professionals, scientific professionals, and other individuals 
who have requested to be included. Through the Listserv and web page, 
FSIS is able to provide information to a much broader, more diverse 
audience.
    For more information, contact the Congressional and Public Affairs 
Office at (202) 720-9113. To be added to the free e-mail subscription 
service (Listserv), go to the ``Constituent Update'' page on the FSIS 
web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov/oa/update/update.htm. Click on the 
``Subscribe to the Constituent Update Listserv'' link, then fill out 
and submit the form.

    Done in Washington, DC, on June 17, 2003.
Garry L. McKee,
Administrator.
[FR Doc. 03-15741 Filed 6-24-03; 8:45 am]