Source: http://thefederalregister.com/2012/11/27/2012-28751.html
Timestamp: 2018-09-23 23:28:42
Document Index: 8928994

Matched Legal Cases: ['art 304', '§ 304', 'art 416', '§ 327', '§ 327', '§ 327', '§ 327', '§ 327', '§ 327', '§ 327', '§ 327', '§ 327', '§ 327', '§ 381', '§ 381', '§ 381', '§ 381', '§ 381', '§ 381', '§ 381', '§ 381', '§ 381', '§ 381', '§ 381', '§ 381', '§ 381', '§ 381', '§ 381']

Federal Register | Electronic Import Inspection Application and Certification of
SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to amend the meat, poultry, and egg products import regulations to provide for the Agency's Public Health Information System (PHIS) Import Component. The PHIS Import Component, launched on May 29, 2012, provides an electronic alternative to the paper-based import inspection application and imported product foreign inspection and foreign establishment certificate processes. In addition, the Agency is proposing to delete the discontinued "streamlined" import inspection procedures for Canadian product and to require Sanitation Standard Operating Procedures (SOPs) at official import inspection establishments. In addition to the proposed regulatory amendments outlined above, FSIS is announcing its intention to discontinue its practice of conducting imported product reinspection based on a foreign government's guarantee to replace a lost or incorrect foreign inspection certificate and is clarifying its policy of addressing imported product that is not presented for reinspection.
DATES: Submit comments on or before January 28, 2013.
ADDRESSES: *Federal eRulemaking Portal:This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go tohttp://www.regulations.gov. Follow the online instructions at that site for submitting comments.
*Mail, including CD-ROMs, etc.:Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163A, Washington, DC 20250-3700.
*Hand- or courier-delivered submittals:Deliver to Patriots Plaza 3, 355 E. Street SW., Room 8-163A, Washington, DC 20250-3700.
Instructions:All items submitted by mail or electronic mail must include the Agency name and docket number FSIS-2009-0022. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, tohttp://www.regulations.gov.
Docket:For access to background documents or comments received, go to the FSIS Docket Room at Patriots Plaza 3, 355 E. Street SW., Room 8-164A, Washington, DC 20250-3700 between 8:30 a.m. and 4:30 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Ms. Mary Stanley, Director, International Policy Division, Office of Policy and Program Development, FSIS, U.S. Department of Agriculture, 1400 Independence Avenue SW., Room 2125, Washington, DC 20250-3700, Phone: (202)720-0287.
The regulations also prescribe a narrative statement and format, certifying that the product was derived from livestock and poultry that received ante-mortem and post-mortem veterinary inspections at the time of slaughter in establishments certified for importation of their products into theUnited States, is not adulterated, and is in compliance with requirements equivalent to domestic requirements. The egg products inspection certificate must certify that the product was produced under the approved regulations, requirements, and continuous government inspection of the exporting country.
Information on implementation of the PHIS Import Component is provided on the FSIS Web site athttp://www.fsis.usda.gov/regulations_&_policies/PHIS_Import_Component/index.asp.FSIS is also coordinating with foreign countries to enable the electronic submission of the foreign establishment and foreign inspection certifications. Any updated information will be posted on the Agency's PHIS Import Component Web site.
Proposed Amendments Foreign Establishment Certification
The product's source information is needed to verify that the source materials are from countries and establishments eligible to export products to the United States, and that the product itself is eligible to be imported into the United States. The product description information, including the process category, the product category, and the product group provides further information about theproduct and assists in accurately assigning product reinspections and laboratory testing. FSIS also collects this information in PHIS for domestic plants. Examples of process categories include: raw product (non-intact)—ground; raw product (intact)—not ground; thermally processed (commercially sterile); not heat treated (shelf stable); heat treated (shelf stable); fully cooked (not shelf stable); and heat treated but not fully cooked (not shelf stable). Within these process categories are the product categories, e.g., raw ground, comminuted, or otherwise non-intact (species); raw intact (species); not ready-to-eat otherwise processed (species); ready-to-eat dried meat; and ready-to-eat fully cooked (species). Within the product categories are the product groups, e.g., ground beef, hamburger, carcass, primals, sausage, ham, soups. FSIS will issue guidelines to assist foreign governments in completing the process category, product category, and product group portion of the foreign inspection certificate.
In response to a congressional request, the General Accounting Office (now known as the Government Accountability Office, or GAO) reviewed, among other things, how the streamlined inspection procedures differed from past procedures, and how the procedures affected the imported product rejection rate between 1988 and 1989. The GAO issued its findings in July 1990.1
1“Food Safety—Issues USDA Should Address Before Ending Canadian Meat Inspections,” United States General Accounting Office Report to Congressional Requestors AO/RCED-90-176, July 1990.
As discussed above, 9 CFR 327.6(e) requires that official import inspection establishments, as a condition of approval, meet the sanitation requirements in 9 CFR 416.1 through 416.6. However, the requirements donot include the Sanitation SOPs in 9 CFR 416.11 through 416.17. Sanitation SOPs are written procedures official establishments are required to develop, implement, and maintain to prevent the direct contamination or adulteration of meat or poultry products.
The PHIS Import Component enables FSIS import inspection personnel to verify import shipments using electronic data. The Agency estimates that electronic imported productinformation reduces the data-entry time for import inspectors by 50 to 60 percent. This does not mean that the Agency is going to reduce the number of import inspectors based on enhanced PHIS-related efficiencies. This proposed rule streamlines existing import documentation requirements by making the foreign inspection certificate consistent among meat, poultry, and egg products. In addition, the proposed rule updates the required information on applications and certificates to fortify the effectiveness of import inspection regulations. For example, for the import inspection application (FSIS Form 9540-1), the Agency is proposing to require the source country and establishment number when the source materials originate from a country other than the exporting country and the product's production dates. The additional information would help verify that source products are from countries and establishments eligible to export products to the United States, and that the product itself is eligible for importation. The additional information will also assist inspection and enforcement personnel in tracing, retrieving, and controlling product in the event of a recall.
(1)The electronic foreign inspection and foreign establishment certificates and the electronic import inspection application.Under this proposed rule, the industry would have the option of filing import inspection applications electronically, and foreign governments would have the option of submitting electronic inspection and foreign establishment certifications and data. Since the electronic option is voluntary, applicants and the foreign countries would choose to file electronically only if it is beneficial to do so.
(2)Additional information entry.This proposed rule, if finalized, requires additional information for the import inspection application, which will increase the amount of time to fill out the application. The time needed to provide the additional information will depend on (1) the number of lots, and (2) how the information is entered.
For applicants that submit a paper-based import inspection application, FSIS estimates that it will take 6 more minutes to complete the new application, based on a comparison between the old and the new paper-based application. FSIS also estimates that electronically filing the import inspection application will take, on average, an additional minute per application in comparison with the old paper-based application.2 Agency data show that there are, on average, a total of 44,480 applications per year that will be filed electronically using the ACE, and that 2,317 applications per year will be completed manually.3 Therefore, the total additional time for electronically filing the application will be 741 hours (44,480 * 1/60 = 741) and the additional time for completing the new paper-based application will be 232 hours (2,317 * 6/60 = 232). Monetizing these hours by $37 perhour,4 the estimated cost to complete the new application would be about $36,000 ($37 * (232 + 741)) per year.
2Time estimate from International Policy Division, Office of Policy and Program Development, FSIS, USDA.
3Number of applications from International Policy Division, Office of Policy and Program Development, FSIS, USDA.
4Bureau of Labor Statistics “Occupational Employment & Wages” Database, May 2010. Animal Production Managers, all other $51.54 @ 47.6% time; General and Operations Managers $33.08 @ 26.2% time; Food scientists and technologists $14.49 @ 26.2% time = $37.00 Managerial Median hourly wage.
In accordance with section 3507(j) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501et seq.), the information collection requirement included in this proposed rule concerning the Import Inspection Application (FSIS Form 9540-1) was submitted to OMB for approval as part of the Public Health Information System (PHIS) information collection request. At that time, FSIS anticipated the changes to the Import Inspection Application that it is now proposing and described them in the PHIS information collection request to OMB, which approved the information collection and assigned it OMB control number 0583-0153.
Title:Electronic Import Inspection
Type of Collection:New
Abstract:Under this proposed rule, FSIS is proposing to require foreign governments to submit additional information when submitting both the foreign establishment certificate and the foreign inspection certificate to FSIS in order for foreign establishments to be permitted to import product to the United States. The current information collection associated with these two certificates is approved under OMB control number 0583-0094.
FSIS is also proposing to require official import inspection establishments to develop, implement, and maintain written Sanitation Standard Operating Procedures (SSOPs), as provided in 9 CFR 416.11 through 416.17.5
5The “Benefits and costs of the proposed rule” section (above) did not include Sanitation Standard Operating Procedures (Sanitation SOPs) costs. While not currently required, in practice, Import Inspection Establishments maintain Sanitation SOPs; therefore, the proposed rule would not be adding any further costs to import inspection establishments. However, incorporating the Sanitation SOPs into FSIS's regulations requires OMB approval of the associated information collection burden. The cost analysis also did not address the expanded questions addressed to foreign governments because the costs would be experienced by foreign entities.
Estimate of Burden:FSIS estimates that it will take 27.8 hours per foreign government (foreign establishment and foreign inspection certificates) and 157.6 hours per official import inspection establishment (SSOP requirements).
Respondents:Foreign governments (foreign establishment and foreign inspection certificates) and official import inspection establishments (SSOP requirements).
Estimated Number of Respondents:30 foreign governments and 120 official import inspection establishments.
Estimated Number of Responses per Respondent:556 responses per foreign government and 523 responses per official import inspection establishments annually.
Estimated Total Annual Burden on Respondents:834 hours for foreign governments and 18,920 hours for official import inspection establishments for a total of 19,754 hours.
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.
FSIS will announce this rule online through the FSIS Web page located athttp://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp
FSIS will also make copies of thisFederal Registerpublication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations,Federal Registernotices, FSIS public meetings, and other types of information that could affect or would be of interest to constituents and stakeholders. The Update is communicated via Listserv, a free electronic mail subscription service for industry, trade groups, consumer interest groups, health professionals, and other individualswho have asked to be included. The Update is also available on the FSIS Web page. In addition, FSIS offers an electronic mailsubscription service which provides automatic and customized access to selected food safety news and information. This service is available athttp://www.fsis.usda.gov/News_&_Events/Email_Subscription/.
List of Subjects 9 CFR Part 304
2. In § 304.3, revise paragraph (a) to read as follows:
(a) Before being granted Federal inspection, an official establishment or an official import inspection establishment must have developed written Sanitation Standard OperatingProcedures, as required by part 416 of this chapter.
4. In § 327.1, revise paragraph (a) to read as follows:
(1)Import (imported).To bring within the territorial limits of the United States whether that arrival is accomplished by land, air, or water.
(2)Offer(ed) for entry.The point at which the importer presents the imported product for reinspection.
(3)Entry (entered).The point at which imported product offered for entry receives reinspection and is marked with the official mark of inspection, as required by § 327.26.
5. In § 327.2, revise paragraph (a)(3) to read as follows:
§ 327.2 Eligibility of foreign countries for importation ofproducts into the United States.
6. Revise § 327.4 to read as follows:
(d) The paper foreign inspection certificate must accompany each consignment, be submitted to import inspection personnel at the official import inspection establishment, be in English, andbear the signature of the official authorized to issue inspection certificates for products imported to the U.S.
7. Revise § 327.5 to read as follows:
§ 327.5 Import inspection application.
(c) The provisions of this section do not apply to products that are exempted from inspection by §§ 327.16 and 327.17.
8. In § 327.6, revise paragraphs (a) and (e) to read as follows:
(a)(1) Except as provided in§§ 327.16 and 327.17, all products offered for entry from any foreign country shall be reinspected by a Program inspector before they shall be allowed entry into the United States.
10. In § 381.1, in paragraph (b), add a definition forOfficial establishmentin alphabetical order to read as follows:
§ 381.1 Definitions.
Official import inspection establishment.This term means any establishment, other than an official establishment as defined in this paragraph where inspections are authorized to be conducted as prescribed in § 381.199.
11. In § 381.22, revise paragraph (a) to read as follows:
§ 381.22 Conditions for receiving inspection.
12. In § 381.195, revise paragraph (a) to read as follows:
§ 381.195 Definitions; requirements for importation into the United States.
(3)Entry (entered).The point at which imported product offered for entry receives reinspection and is marked with the official mark of inspection, as required by § 381.204.
13. In § 381.196, revise paragraph (a)(3) to read as follows:
14. Revise § 381.197 to read as follows:
§ 381.197 Foreign inspection certificate requirements.
(a) Except as provided in §§ 381.207 and 381.209, each consignment imported into the United States must have an electronic foreign inspection certification or a paper foreign inspection certificate issued by an official of the foreign government agency responsible for the inspection and certification of the product.
(b) An official of the foreign government must certify that any product described on any official certificate was produced in accordance with the regulatory requirements in § 381.196.
15. Revise § 381.198 to read as follows:
§ 381.198 Import inspection application.
(b) Import inspection applications for each consignment must be submitted (electronically or paper) to FSIS in advance of the shipment's arrival at the official import establ