63254 Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Rules and Regulations

of nonimmigrant visas to immigrate to

this country.

Accordingly, no changes have been

made as a result of these comments.

Regulatory Flexibility Act

In accordance with 5 U.S.C. 605(b),

the Commissioner of the Immigration

and Naturalization Service certifies that

this rule will not, if promulgated, have

a significant adverse economic impact

on a substantial number of small

entities. This rule allows certain

nationals of the PRC to apply for

adjustment of status; it has no effect on

small entities as that term is defined in

5 U.S.C. 601(6).

Executive Order 12866

This rule is not considered by the

Department of Justice, Immigration and

Naturalization Service, to be a

‘‘significant regulatory action’’ under

Executive Order 12866, section 3(f),

Regulatory Planning and Review, and

the Office of Management and Budget

has waived its review process under

section 6(a)(3)(A).

Executive Order 12612

The regulation will not have

substantial direct effects on the States,

on the relationship between the

National Government and the States, or

on the distribution of power and

responsibilities among the various

levels of government. Therefore, in

accordance with Executive Order 12612,

it is determined that this rule does not

have sufficient federalism implications

to warrant the preparation of a

Federalism Assessment.

Small Business Regulatory Enforcement

Fairness Act of 1996

This rule is not a major rule as

defined by section 804 of the Small

Business Regulatory Enforcement Act of

1996. This rule will not result in an

annual effect on the economy of $100

million or more; a major increase in

costs or prices; or significant adverse

effects on competition, employment,

investment, productivity, innovation, or

on the ability of United States-based

companies to compete with foreignbased companies in domestic and

export markets.

Executive Order 12988 Civil Justice

Reform

This interim rule meets the applicable

standards set forth in section 3(a) and

3(b)(2) of E.O. 12988.

Unfunded Mandates Reform Act of

1995

This rule will not result in the

expenditure by State, local and tribal

governments, in the aggregate, or by the

private sector, of $100 million or more

in any 1 year, and will not significantly

or uniquely affect small governments.

Therefore, no actions were deemed

necessary under the provisions of the

Unfunded Mandates Reform Act of

1995.

List of Subjects in 8 CFR Part 245

Aliens, Immigration, Reporting and

recordkeeping requirements.

Accordingly, the interim rule

amending 8 CFR part 245 which was

published at 58 FR 35832 on July 1,

1993, is adopted as a final rule with the

following change:

PART 245—ADJUSTMENT OF STATUS

TO THAT OF A PERSON ADMITTED

FOR PERMANENT RESIDENCE

1. The authority citation for part 245

continues to read as follows:

Authority: 8 U.S.C. 1101, 1103, 1182, 1255;

8 CFR part 2.

2. In § 245.9, paragraph (m) is revised

to read as follows:

§ 245.9 Adjustment of Status of Certain

Nationals of the People’s Republic of China

under Public Law 102–404.

* * * * *

(m) Effect of enactment on family

members other than qualified family

members. The adjustment of status

benefits and waivers provided by Public

Law 102–404 do not apply to a spouse

or child who is not a qualified family

member as defined in paragraph (c) of

this section. However, a spouse or child

whose relationship to the principal

alien was established prior to the

approval of the principal’s adjustmentof-status application may be accorded

the derivative priority date and

preference category of the principal

alien, in accordance with the provisions

of section 203(d) of the Act. The spouse

or child may use the priority date and

category when it becomes current, in

accordance with the limitations set forth

in sections 201 and 202 of the Act.

Dated: October 31, 1997.

Doris Meissner,

Commissioner, Immigration and

Naturalization Service.

[FR Doc. 97–31033 Filed 11–26–97; 8:45 am]

BILLING CODE 4410–10–M

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 301, 307, 308, 310, 318,

381, 416, and 417

[Docket No. 97–067N]

Livestock Carcasses and Poultry

Carcasses Contaminated With Visible

Fecal Material

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Notice on complying with food

safety standards under the HACCP

system regulations.

SUMMARY: The Food Safety and

Inspection Service is publishing this

notice to assure that the owners and

operators of federally inspected

slaughter establishments are aware that

the Agency views its ‘‘zero tolerance’’

for visible fecal material as a food safety

standard. Fecal material is a vehicle for

microbial pathogens, and

microbiological contamination is a food

safety hazard that is reasonably likely to

occur in the slaughter production

process. In controlling microbiological

contamination, a hazard analysis and

critical control point plan for slaughter

must be designed, among other things,

to ensure that, by the point of postmortem inspection of livestock

carcasses or when poultry carcasses

enter the chilling tank, no visible fecal

material is present.

FOR FURTHER INFORMATION CONTACT:

Patricia F. Stolfa, Assistant Deputy

Administrator, Regulations and

Inspection Methods, Food Safety and

Inspection Service, Washington, DC

20250–3700; (202) 205–0699.

SUPPLEMENTARY INFORMATION: The Food

Safety and Inspection Service (FSIS)

administers a regulatory program under

the Federal Meat Inspection Act (FMIA)

(21 U.S.C. 601 et seq.) and the Poultry

Products Inspection Act (PPIA) (21

U.S.C. 451 et seq.) to protect the health

and welfare of consumers by preventing

the distribution of livestock products

and poultry products that are

unwholesome, adulterated, or

misbranded. A livestock product or

poultry product is adulterated under

any of a number of circumstances,

including the following: if it bears or

contains any poisonous or deleterious

substance which may render it injurious

to health, unless when the substance is

not an added substance, the quantity in

or on the article does not ordinarily

render it injurious to health; if it

consists in whole or in part of any

filthy, putrid, or decomposed substance

or is for any other reason unsound,

unhealthful, unwholesome, or otherwise
Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Rules and Regulations 63255

1Part 417 requirements, as well as pathogen

reduction performance standards for Salmonella in

establishments that slaughter cattle, swine,

chickens, or turkeys, prepare ground beef or fresh

pork sausage, or process ground chicken or turkey

(§§ 310.25(b) and 381.94(b)) will apply as of January

26, 1998, in establishments with 500 or more

employees; January 25, 1999, in establishments

with 10 or more but fewer than 500 employees

(unless the establishment has annual sales of less

than $2.5 million); and January 25, 2000, in

establishments with fewer than 10 employees or

annual sales of less than $2.5 million.

unfit for human food; or if it has been

prepared, packed, or held under

unsanitary conditions whereby it may

have become contaminated with filth or

whereby it may have been rendered

injurious to health (21 U.S.C. 453(g)(1),

(g)(3), and (g)(4) and 601(m)(1), (m)(3),

and (m)(4)). Both the FMIA and the

PPIA include requirements for

government inspection and prohibit

transactions in products required to be

inspected unless they have been

‘‘inspected and passed’’ or if they are

adulterated (21 U.S.C. 458(a)(2) and

610(c)).

FSIS enforces a ‘‘zero tolerance’’

standard for visible fecal material on

carcasses and carcass parts at inspected

establishments that slaughter livestock

or poultry. This standard is reflected in

the Agency’s regulations under the

FMIA and the PPIA (9 CFR chapter III,

subchapter A and subchapter C,

respectively), which require (among

other things) that establishments handle

livestock carcasses and carcass parts to

prevent contamination with fecal

material and promptly remove

contamination if it occurs (§ 310.18) and

that establishments prevent poultry

carcasses contaminated with visible

fecal material from entering the chilling

tank (§ 381.65(e)). When inspection

program personnel observe fecal

material at post-mortem livestock

inspection or thereafter (i.e., at or after

the final rail) under the FMIA or when

poultry carcasses are about to enter the

chilling tank or thereafter (i.e., at any

point after the final pre-chiller wash)

under the PPIA, they condemn affected

carcasses and carcass parts unless the

contamination is removed in accordance

with regulatory requirements.

The Agency is publishing this notice

to assure that the owners and operators

of federally inspected slaughter

establishments are aware that FSIS

regards its zero tolerance for visible

fecal material as a food safety standard

under both the FMIA and the PPIA.

Reiterating the Agency’s position is

particularly appropriate now, as

federally inspected establishments

prepare to comply with the hazard

analysis and critical control point

(HACCP) system regulations (part 417).1

The essence of FSIS’s position is that

fecal material is a vehicle for microbial

pathogens, and microbiological

contamination is a food safety hazard

that is reasonably likely to occur in the

slaughter production process (§ 417.2(a)

and (b)). Consequently, HACCP plans

must control for microbiological

contamination at slaughter, and to meet

the zero tolerance standard, an

establishment’s controls must (among

other things) include limits that ensure

that no visible fecal material is present

by the point of post-mortem inspection

of livestock carcasses or before poultry

carcasses enter the chilling tank

(§ 417.2(c)).

In the Pathogen Reduction-HACCP

Systems final rule (61 FR 38806, July 25,

1996), FSIS explained the reasoning

underlying its position on fecal

contamination, and at the beginning of

this year, FSIS addressed the role of its

zero tolerance for visible fecal material

on poultry carcasses in the final rule

that codified the standard under the

PPIA (62 FR 5139, February 4, 1997).

Preparation for implementation of the

HACCP system regulations has not

changed the Agency’s conclusions about

the appropriateness of this standard,

under the FMIA as well as the PPIA.

As the Agency stated in the Pathogen

Reduction-HACCP Systems final rule

(61 FR 38837):

In slaughter establishments, fecal

contamination of carcasses is the primary

avenue for contamination by pathogens.

Pathogens may reside in fecal material and

ingesta, both within the gastrointestinal tract

and on the exterior surfaces of animals going

to slaughter. Therefore, without care being

taken in handling and dressing procedures

during slaughter and processing, the edible

portions of the carcass can become

contaminated with bacteria capable of

causing illness in humans. Additionally,

once introduced into the establishment

environment, the organisms may be spread

from carcass to carcass.

Because the microbial pathogens

associated with fecal contamination are the

single most likely source of potential food

safety hazard in slaughter establishments,

preventing and removing fecal contamination

and associated bacteria are vital

responsibilities of slaughter establishments.

Further, because such contamination is

largely preventable, controls to address it

will be a critical part of any slaughter

establishment’s HACCP plan. Most slaughter

establishments already have in place

procedures designed to prevent and remove

visible fecal contamination.

As noted in the zero tolerance final

rule and confirmed today with respect

to livestock as well as poultry,

establishments that process animals

must adopt controls that they can

demonstrate are effective in reducing

the occurrence of microbial pathogens,

including controls that prevent the fecal

contamination of carcasses (62 FR

5140). Under the HACCP system

regulations, critical control points to

eliminate contamination with visible

fecal material are predictable and

essential components of all slaughter

establishments’ HACCP plans. Initial

validation of a HACCP plan for

slaughter and monitoring thereunder, as

verified and documented in

establishment records, must

demonstrate the effective operation of

the plan’s controls on a continuing basis

(§§ 417.3(a), 417.4, and 417.5).

FSIS personnel will continue to verify

compliance with the zero tolerance

standard in slaughter establishments

that are subject to part 417

requirements. The Agency will use

visual observations and other findings

by FSIS personnel in evaluating the

effectiveness of an establishment’s

preventive controls and corrective

actions for fecal contamination (§§ 417.6

and 417.8). The presence of visible fecal

contamination on livestock carcasses

presented for post-mortem inspection or

poultry carcasses entering the chilling

tank will mean that establishment

controls have failed; repeated failures

will evidence that establishment

corrective actions have failed to prevent

recurrence and, thus, possible system

inadequacy.

In addition to enforcing the zero

tolerance for visible fecal material, FSIS

will use the results of establishment

testing for generic E. coli (Escherichia

coli Biotype I, as already required by

§ 310.25(a) or § 381.94(a)) in assessing

how well an establishment is

controlling its slaughter and dressing

processes to prevent fecal

contamination. The pathogen reduction

performance standards for Salmonella

(§§ 310.25(b) and 381.94(b)), which FSIS

will enforce through its own testing

program, will complement the zero

tolerance standard and E. coli testing.

Done at Washington, DC, on November 18,

1997.

Thomas J. Billy,

Administrator.

[FR Doc. 97–31176 Filed 11–26–97; 8:45 am]

BILLING CODE 3410–DM–P