[Code of Federal Regulations]

[Title 9, Volume 2]

[Revised as of January 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 9CFR327.23]



[Page 353-355]

 

                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS

 

     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 

                               AGRICULTURE

 

PART 327_IMPORTED PRODUCTS--Table of Contents

 

Sec. 327.23  Compliance procedure for cured pork products offered for 

entry.



    (a) Definitions. For the purposes of this section:

    (1) A Product is that cured pork article which is contained within 

one Group as defined in paragraph (a)(2) of this section and which 

purports to meet the criteria for a single product designated under the 

heading ``Product Name and Qualifying Statements'' in the chart in Sec. 

319.104 or Sec. 319.105 of this subchapter.

    (2) A Product Group or a Group means one of the following:

    (i) Group I, consisting of cured pork products which have been 

cooked while imperviously encased. Any product that fits into the Group 

shall be placed in this Group regardless of any other considerations.

    (ii) Group II, consisting of cured pork products which have been 

water cooked. Any product that does not fit into Group I but does fit 

into Group II shall be placed into Group II regardless of any other 

considerations.

    (iii) Group III, consisting of boneless, smokehouse heated cured 

pork products. Any boneless product that does not fit into Group I or II 

shall be placed in Group III.

    (iv) Group IV, consisting of bone-in or semi-boneless smokehouse 

heated cured pork products. Any product that is not completely boneless 

or still contains all the bone which is traditional for bone-in product 

and does not fit into Group I, II, or III shall be placed in this Group.

    (3) Protein Fat-Free Percentage, Protein Fat-Free Content, PFF 

Percentage, PFF Content or PFF of a product means the meat protein 

(indigenous to the raw, unprocessed pork cut) content expressed as a 

percent of the non-fat portion of the finished product.

    (4) A PFF Standardized Difference is the PFF of the sample minus the 

minimum PFF requirement, set forth in Sec. 319.104 and Sec. 319.105 of 

this subchapter, for the product being analyzed, divided by the 

Appropriate Standard Deviation for the product group.

    (5) The Absolute Minimum PFF Requirement is that no laboratory 

result



[[Page 354]]



of an individual sample for PFF content be below the applicable minimum 

requirement of Sec. 319.104 or Sec. 319.105 of this subchapter by 2.3 

or more percentage points for a Group I or II product or 2.7 or more 

percentage points for a Group III or IV product.

    (6) A PFF Standardized Arithmetic Average of the Country's Products 

is the arithmetic average of PFF Standardized Differences from either 36 

or 100 consecutively sampled lots of product entering the United States 

from a given producing country.

    (7) A PFF Standardized Weighted Average of the Country's Products is 

an estimate of the average of the PFF Standardized Differences from 

either 36 or 100 consecutively sampled lots, adjusted for the size of 

the lot, of different types of cured pork product entering the United 

States from a given producing country. A Standardized Weighted Average 

is computed by multiplying the PFF Standardized Difference calculated 

for each lot by the number of pounds of product in each lot, adding 

those results together, and dividing the sum by the total weight of 

product from all the lots making up the average.

    (8) The Appropriate Standard Deviation is based on within lot 

variability. That assigned to Groups I and II = 0.75 percent PFF and 

that assigned to Groups III and IV = 0.91 percent PFF.

    (9) A Lot is all product of one type from one establishment 

presented by an importer as the unit for inspection at the Port of 

Entry.

    (b) Normal monitoring procedures. Except for product imported from 

Canada, the Department shall collect sample(s) of cured pork product on 

a random basis from lots offered for entry at the Port of Entry and, 

after analyzing the sample for fat and indigenous protein content, 

calculate the PFF percentage. The product shall not be held pending 

laboratory results during the monitoring phase. The PFF percentage for 

each sample shall be considered along with the cumulative results of 

prior samples to assess the effectiveness of a country's overall 

compliance program and to determine the course of action for subsequent 

lots of product.

    (1) Factors determining whether a country's inspection system is 

functioning adequately:

    (i) The PFF percentage for each sample must not be below the minimum 

PFF requirement by 2.3 percentage points for cured pork products in 

Groups I and II or 2.7 percentage points for cured pork products in 

Groups III and IV.

    (ii) Both of the PFF Standardized Averages, Arithmetic and Weighted, 

for the last 100 consecutive lots of all cured pork products from the 

country must be equal to or greater than zero. The count for the 100 

consecutive lots starts with the lots arriving from that country after 

April 15, 1985.

    (iii) Both of the PFF Standardized Averages, Arithmetic and 

Weighted, for the last 36 consecutive lots of all cured pork products 

from the country must be above the lowest 5 percent of the Normal 

distribution. This minimum value is minus 0.28 (-0.28) for the 

Arithmetic Average and depends on the production volume for the Weighted 

Average.

    (2) Actions when calculations indicate that processing procedures in 

a country are out-of-compliance:

    (i) If the PFF level of a sample taken during normal monitoring 

procedures is found to be as low as the Absolute Minimum PFF 

Requirement, the country of origin shall be notified; the lot involved 

shall be retained if still available in an official establishment or 

subject to detention or other actions pursuant to the Act; and all 

subsequently presented lots of that cured pork product from the same 

foreign establishment shall be held under retention until the provisions 

of paragraph (c) are satisfied.

    (ii) If either of the PFF Standardized Averages, Arithmetic or 

Weighted, for the last 100 consecutive lots falls below zero or either 

of the PFF Standardized Averages for the last 36 consecutive lots falls 

below the upper 95 percent of the Normal distribution, all available 

cured pork product from the foreign country shall be subject to 

administrative retention and all subsequently presented lots of cured 

pork product from the foreign country shall be held under retention 

until the provisions of paragraph (c) are satisfied. The country of



[[Page 355]]



origin shall be notified, and shall be subject to other actions pursuant 

to the Act.

    (c) Retention. When lots of cured pork product are under retention 

they shall be refused entry and reexported in accordance with Sec. 

327.13 of this subchapter unless they can be released in accordance with 

the provisions of paragraph (c)(1), establishments may be returned to 

normal monitoring procedures in accordance with paragraph (c)(2), and 

countries may be returned to normal monitoring procedures in accordance 

with paragraph (c)(3).

    (1) If a lot is subject to retention procedures under this section, 

the Department shall collect five randomly selected sample units from 

each lot and determine the PFF of each sample unit. The lot may be 

released into commerce if:

    (i) The average PFF percentage of the five randomly selected sample 

units is equal to or greater than the applicable minimum PFF percentage 

required by Sec. 319.104 or Sec. 319.105 of this subchapter, or

    (ii) The product is relabeled under the supervision of a program 

employee so that it conforms to the provisions of Sec. 319.104 or Sec. 

319.105 of this subchapter.

    (2) If product from a foreign establishment is subject to retention 

procedures under this section, the foreign establishment may be returned 

to normal monitoring procedures when:

    (i) Ten consecutively presented lots of that cured pork product from 

that establishment have been sampled as provided in paragraph (c)(1) of 

this section and the average of each set of five sample units 

representing each lot have been found to be equal to or greater than the 

required minimum PFF percentage; and

    (ii) The PFF percentage of each sample unit (50 in all) is above the 

Absolute Minimum PFF Percentage.

    (3) If a country is subject to retention procedures under this 

section, the country shall be returned to normal monitoring procedures 

when:

    (i) Twenty-five consecutively presented lots of cured pork product 

have been sampled as required in paragraph (c)(1) of this section and 

the average of each set of five sample units representing each lot have 

been found to be equal to or greater than the required minimum PFF 

percentage; and

    (ii) The PFF percentage of each sample unit (125 in all) is above 

the Absolute Minimum PFF Percentage; and

    (iii) Both of the PFF Standardized Averages for 36 consecutive lots 

are in the required percentage of the Normal distribution; and

    (iv) Both of the PFF Standardized Averages for 100 consecutive lots 

are zero or higher.

    (4) The sample units collected under retention procedures as 

provided in paragraph (c)(2) of this section will not be included in the 

PFF standardized averages for 36 and 100 consecutive lots.

    (d) Adulterated and Misbranded Products. Products not meeting 

specified PFF requirements, determined according to procedures set forth 

in this section, may be deemed adulterated under section 1(m)(8) of the 

Act (21 U.S.C. 601(m)(8)) and misbranded under section 1(n) of the Act 

(21 U.S.C. 601(n)).

    (e) Activities requiring additional inspectional supervision, such 

as relabeling, shall be at the importer's expense. In addition, if the 

importer wishes, he or she may have samples analyzed at an accredited 

laboratory.



[50 FR 9792, Mar. 12, 1985, as amended at 54 FR 41049, Oct. 5, 1989]