| Comment Record |
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Commentor |
Mr. William Hackett |
Date/Time |
2003-04-04 16:43:21 |
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Organization |
Barton Beers, Ltd. |
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Category |
Food Industry |
| Comments for FDA General |
| Questions |
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1. General Comments
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April 4, 2003
Food and Drug Administration
Dockets Management Branch
(HFA-305)
5630 Fisher Lane, Room 1061
Rockville, MD 20852
ATTN: Dockets Management Branch – (Docket No. 02N-0278)
Prior Notice of Imported Food Under the Public Health Security And Bioterrorism Preparedness and Response Act of 2002
Dear Sir/Madam:
These comments are submitted by Barton Beers, Ltd. (“Barton”). Barton imports beer from Mexico, Germany, China, Italy and England for sale in the United States. Beer brands represented by Barton include Corona, St. Pauli Girl, Peroni, Tsingtao and Tetley’s.
Barton appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its proposed regulations implementing the provisions of the Bioterrorism Preparedness and Response Act of 2002, (hereafter referred to as “the Act”) that deals with “Prior Notice.” We believe FDA has proposed regulations that are unnecessary for the proper performance of FDA’s functions. These proposed regulations duplicate the information submissions already made to another Federal agency and for the same reasons - the prevention and detection of terrorism. These proposed regulations would also cause Barton to submit duplicative prior notice information to more than one federal agency since the U.S. Customs Service currently requires ocean carriers to submit cargo information to the U.S. Customs 24-hours before the cargo is loaded onto a ship destined for a United States port.
This duplication seems to directly contradict FDA’s own words contained in paragraph C(3), Requirements to Submit Prior Notice of Imported Food. In that paragraph, FDA said the following: “FDA seeks to minimize the submission of duplicative information. The Bioterrorism Act requires certain prior notice information to be submitted to FDA. FDA seeks comments on the extent to which these proposed prior notice requirements would result in persons submitting duplicative prior notice information to more than one federal agency.
FDA also seeks comments on whether there is a way, consistent with the requirements and purpose of the Bioterrorism Act, to minimize the duplication of information required to be submitted to the federal government under these prior notice requirements.”
We understand that FDA and Customs are working together on their systems to allow prior notice to be submitted to FDA through the U.S. Customs system when ACE is fully operational. We applaud this cooperative effort between FDA and U.S. Customs, but we believe it has not gone far enough. We understand that ACE will be fully operational in 2005. In the meantime rather than accept the information currently submitted to U.S. Customs through the “24-hour rule,” the normal entry documentation, and the OASIS system, FDA is proposing to setup a stand alone system that is totally redundant and is prepared to require the importing industry to resubmit all of the data it has already submitted to U.S. Customs. In addition, FDA fully admits that its system will be redundant when the U.S. Customs system is up and running in 2005, a mere 12 months after of FDA establishment of its stand alone, redundant system.
We believe FDA has the authority under the law to recognize the submissions to the U.S. Customs Service as satisfying the prior notice requirements of the Act. We urge FDA not to adopt any regulations that would be duplicative of regulations already in place and administered by other federal agencies. In that regard, Sections 302 (c) and 314 clearly contemplate and direct the efficient use of government resources to effectuate the goals of this Act and to facilitate its implementation by a clear allocation of federal agency activities. The Congressional Record is evidence of such intent.
The Senate proposal authorized the “Secretary” to require the maintenance and retention of other records relating to food safety in consultation with other federal departments and agencies that regulate food safety. (148 Cong Rec H 2685.) Since the Secretary had authority under Section 701(a) of the FFDCA to issue regulations for the efficient enforcement of the Act in combination with other provisions, the Senate proposal was not adopted. (148 Cong Rec H 2685.)
The House of Representatives also advocated close coordination with other Federal agencies, such as U.S. Customs Service, in implementing the prior notice requirement with a goal of minimizing and eliminating unnecessary, multiple and redundant notifications (147 Cong Rec E 2388) and encouraging simplicity and cooperation with respect to the registration requirement, reducing paperwork and the reporting burden on facilities (147 Cong Rec E 2388.) Therefore, Congress recognized that the Act called upon functions of other federal agency activities and intended to coordinate, rather than duplicate, such functions.
Understanding the need to immediately obtain information relating to foods imported or offered for import into the United States in reaction to a crisis, Barton urges the FDA to implement a coordinated strategy with other federal agencies that have established regulatory measures governing beverage alcohol. This clear allocation of federal agency activities, such as Customs vis-à-vis its respective regulatory schemes governing imported beverage alcohol, will best utilize the procedures and processes already in place to most efficiently “develop a crisis communications and education strategy with respect to bioterrorist threats to the food supply” – the stated purpose of Title III of the Act.
FDA considered five (5) options in the NPRM. None of the options, however, contain an analysis of FDA’s accepting another agency’s prior notice system under the Bioterrorism Act. The cost of this option would be significantly less – for both government and industry – than the option being proposed by FDA. None of the options contemplated by FDA considers “low risk” or “known importers.” FDA could lessen the burden on itself and on the regulated industries by considering an option that would be less intrusive and burdensome on “low risk” importers. This would include importers that have been accepted into the U.S. Customs and Trade Partnership Against Terrorism (C-TPAT). C-TPAT members have been screened by the U.S. Customs Service. They and their supply chain have been carefully examined by the U.S. Customs Service and have spent large sums of money to safeguard the food supply chain. C-TPAT applicants were promised that they would enjoy preferential treatment when entering cargo into the United States. The regulation now proposed by FDA would eliminate most of the benefits of C-TPAT membership.
We will now address the specific questions asked relating to the Paperwork Reduction Act of 1995.
1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility
The collection of the information in question in a “stand alone” FDA system is duplicative. The proposed regulations appear to have been written without taking into consideration the “24 hour” rule implemented by the U.S. Customs Service on February 3, 2003. Under this new rule an ocean carrier must supply the U.S. Customs Service with detailed manifest information twenty-four (24) hours in advance of the cargo being loaded on the ship in the port of embarkation. The manifest information, the entry paperwork, and the OASIS system, all on file with the U.S. Customs Service, clearly satisfy the prior notification requirements of the Act.
We have compared the information required by these proposed regulations and the information currently submitted to U.S. Customs when an importer makes an entry. Our comparison revealed that all of the information FDA needs for its purposes is already available in the U.S. Customs entry documentation or is readily available in other commercial records, if needed.
Even if FDA can gather the information from either the U.S. Customs Service or from its own stand alone system, FDA has not made it clear as to how it will use the information. The number of “prior notices” will be so voluminous it is doubtful FDA will be able to do anything meaningful with it that U.S. Customs is not already doing. Accordingly, we do not feel this requirement to file duplicative information with the FDA will have practical utility or benefit that would outweigh the additional burden on businesses.
Barton believes the data elements and the fields on the submission forms are excessive and do not, in some cases, provide meaningful information or have practical utility. FDA’s request for information on this prior entry form exceeds the scope and intent of the statutory mandate. For example:
(a) Asking the name of a grower from an importer trying to import a container is a request for useless information even if the importer was, in fact, able to identify the many growers whose products comprised a part of the product we are importing.
(b) Lot codes are not required for alcohol beverages produced in a number of the countries that are U.S. trading partners. The prior notice form should only request the information mandated by Federal law.
(c) The registration number should be sufficient to allow for the automatic completion of the name and address fields.
In addition, we find the FDA requirement that a prior notice be filed for each size of the same product from the same manufacturer in a single container to be an excessive and burdensome requirement not mandated by law nor is it useful or of any practical utility.
2) The accuracy of FDA’s estimate of the burden of the proposed collection of Information, including the validity of the methodology and assumptions used
We believe the FDA estimate of burden hours caused as a result of the proposed regulations is fatally flawed. A review of Barton’s records for October, 2002 reveals that we would be submitting 2,014 responses under the proposed regulations, not the 23 per month estimated by FDA. This equates annually into 24,168 responses. Converting 24,618 responses into staff years, using the FDA assumption of 23 minutes per line response, equals approximately 4.8 staff years that each company would have to expend to comply with the proposed regulations. That expenditure of money by a company seems to be an unreasonable burden for a company to bear – just to re-submit information already on file with the U.S. Customs Service. You should also bear in mind the average cost to employ a person to do this work in Chicago ranges from $30,000 to $40,000.00 per year.
In addition, we think the number of respondents assumed by FDA is far too low. Using FDA assumptions, alcohol beverage importers would be approximately 5% of all food importers in the United States. Considering the nature and volume of other food imports, that assumption is highly unlikely.
It is obvious this is a major rule with significant impact on small business. Using our assumptions, the aggregate cost to the private sector could easily exceed the $112 million dollar threshold specified in Title II of the Unfunded Mandate Reform Act of 1995. It would appear a cost benefit analysis must be conducted before FDA finalizes these regulations. The proposed rule is a significant rule as defined by that Act.
The following are specific illustrations of the burden and impact the proposed regulations would have Barton and other similar importers.
Entry Lines: FDA used OASIS data to conclude that 4.7 million entry lines for food were imported into the United States in FY 2001. FDA fails to consider the new regulations would mandate prior notice reporting for categories that may never have been filtered through OASIS under the previous system including the packaging components, and alcoholic beverages.
FDA estimates 4.7 million OASIS entries, averaging 2.6 lines each and notes that a prior notice will be required for each line. FDA then divided the entries by the lines to determine the number of prior notices. Barton disagrees with this calculation; 4.7 million must be multiplied by 2.6 “articles of food” under the current proposal to determine prior notice, yielding a total of 12.22 million prior notices.
Barton agrees that, once research is completed and a pattern is established, it would take approximately one hour to complete a full prior notice entry, 15 minutes for the manager and 45 minutes for the administrative worker. This calculation, however, does not take into consideration the time necessary to assemble and verify the detailed information on the proposed form. This will require prior communications with the importer of record, Customs and carriers as well as the supplier, including verification of purchase orders and related contracts.
In addition, FDA has failed to appropriately take into consideration the time involved in amending and updating the information. Barton believes that, with respect to its imports from Mexico, almost every prior notice will require amending and updating. Barton is likely to delegate prior notice filing responsibilities to Customs brokers (agents). A preliminary estimate for a broker’s time would be $50 to file and $20-25 for each amendment or update, which will add even more to the cost of compliance with these new regulations.
Finally, the extent to which manual data entry will be required and whether the form can accommodate several products in the same shipment will have a significant impact upon the actual administrative time required to file.
Impact on Importers: FDA estimates this regulation will affect 77,427 importers. FDA has failed to consider this rule will also affect a large number of foreign suppliers and carriers who will have to adjust reporting procedures and scheduling to accommodate the time frame imposed by this new rule. In Table 24, FDA extrapolates (using the entry line assumption referenced above) that these importers will file an average of 23.3 prior notices annually. Under Barton’s calculations (based upon the current understanding of reporting requirements); FDA would receive over 12 million prior notices. Clearly many large importers will send several shipments across borders each day. A single shipping container with a variety of products, will also, under the proposal, require several prior notices.
3) Ways to enhance the quality, utility, and clarity of the information to be collected
We suggest that the amount and kind of information requested by FDA in the “prior notice” is significantly more than that required by Section 307 of Title III of the Bioterrorism Act. The quality, utility, and clarity of the information would be enhanced if FDA would limit its request for information to only those items specified in the law. For example, the tracking of the actual time of a vessel’s arrival is the responsibility of the U.S. Coast Guard and the ocean carrier not the importer; therefore, amended prior notice concerning a delayed vessel should not be required.
It is important to note here that Section 307 of Title III of the Bioterrorism Act directs the Secretary (HHS) to consult with the Secretary of the Treasury before issuing “prior notice” regulations. It would appear that the Congress was trying to avoid duplication by including this language.
4) Ways to minimize the burden of the collection of information on respondents
The best way to minimize the burden would be for FDA to accept those filings already made with the U.S. Customs Service as the “prior notice” mandated by the Bioterrorism Act.
In the Final Rule, FDA should limit the information requested to that mandated by law.
Conclusion
In summary, Barton recommends that FDA work with other federal agencies that have jurisdiction governing the importation of alcohol beverages in order to coordinate regulatory requirements on the private sector. The U.S. Customs Service and the Tax and Trade Bureau of Treasury both have regulatory authority over the importation of an alcohol beverage. We believe the regulations proposed by FDA unnecessarily duplicate regulations issued by those agencies. FDA should re-evaluate the need for its “prior notice” regulation in light of the 24 hour advance notice now required by the U.S. Customs Service.
FDA should also conduct the costs benefit analysis as required by Title II of the Unfunded Mandate Reform Act of 1995 before it moves to finalize these “prior notice” regulations.
We thank you for this opportunity to comment on these proposed regulations. We stand ready to work with you at any time and to assist FDA in the drafting of regulations that meet the requirements of the law without placing an unnecessary burden on the regulated industry.
If we can be of further assistance, please do not hesitate to call on us.
Sincerely,
Wm F Hackett
President – Barton Beers, Ltd.
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