CPSC PROPOSED CRP RULE MAY COST INDUSTRY "IN EXCESS OF $1 BIL."

CPSC PROPOSED CRP RULE MAY COST INDUSTRY "IN EXCESS OF $1 BIL." to implement, McNeil Consumer Products estimated in May 20 comments to the Consumer Product Safety Commission. "The proposed regulations will have significant adverse, industry-wide economic impact," McNeil asserted, "at a time and climate where consumers are very concerned about containing rising health care costs." The new child-resistant packaging (CRP) testing protocol was proposed on March 21 ("The Tan Sheet" March 28, p. 6).

McNeil placed its own potential retesting costs at between $450,000 and "as high as $1.3 mil.," claiming that additional costs to "re-tool and develop new primary packaging molds for McNeil products could be as high as $2 mil."

In separate May 17 comments, Lederle stated that since 1991, it "has spent $250,000 in developing a modified CR package and is investing $3.3 mil. in custom tooling and manufacturing equipment in order to meet the new requirements." Procter & Gamble noted in May 19 comments that changes to its packages "will take about 12- 15 months and will cost about $500,000 for each package change," not counting "costs of the necessary additional drug product stability requalification" and "stress package testing."

The March 21 proposal is intended to make child-resistant packaging more "senior-friendly" by altering the current testing protocol to include subjects aged 60-75 in the adult effectiveness component of the test. CPSC Chair Ann Brown said at a March press luncheon that she hopes to finalize the CRP protocol by the end of the year ("The Tan Sheet" April 4, p. 7).

CPSC indicated at a February meeting that it has worked closely with industry in developing the revised protocol ("The Tan Sheet" Feb. 14, p. 15). However, CPSC said that it had received more than 30 letters from industry suggesting a wide range of revisions to the proposal, including arguments from the Nonprescription Drug Manufacturers Association. NDMA asserted that accommodating senior adults might compromise the safety of children (see following story).

Compliance with the new protocol is complicated by adherence to FDA regulations, commenters maintained. Including the filing of NDA supplements and product stability data, McNeil said, "testing, submission and FDA review may take years to complete and obtain approval." Lederle said it "identified 22 product/package styles that will need prior stability and approval from FDA before packaging in the new container/closure system can begin."

Technology may also pose a problem, industry argued. CPSC "is underestimating the difficulty of developing technically feasible solutions for the full range of package sizes and pharmaceutical products affected," McNeil contended.

Non-reclosable packaging would be particularly hard hit by the proposed rules, some commenters indicated. P&G recommended that "the final rules impose no changes on blister/pouch approaches" and urged that "separate and serious reconsideration must be given to the technical challenges inherent in non-reclosable packaging" because of "inherent access barriers."

The Healthcare Compliance Packaging Council maintained that "the children's test [component of the protocol] is so unnecessarily stringent...that it results in blister packaging which is extremely difficult for older persons and persons with disabilities to open." The council warned that "if the proposed protocol is adopted, it would likely result in the general availability of only two types of blisters -- neither of which lends itself to a calendar format, and neither of which is truly easy to open for most older persons."

Objecting to the CRP proposed rule's effective date, the child-resistant packaging subcommittee of the American Society for Testing and Materials (ASTM) stated that "it would be impossible for current child-resistant packaging to be tested for compliance with the new protocol within one year of publication" of a final rule.

McNeil and the Closure Manufacturers Association agreed that a one-year effective date is "not feasible." McNeil stated that CRP testing for its products "would potentially demand test-agency resources for years." The ASTM subcommittee calculated that the testing capacity of national labs is 144 packages per year, while the number of existing product/package styles is "conservatively" estimated at 320-640.

"It's virtually impossible for testing of all [applicable U.S.] products by the limited number of test facilities to be accomplished within a one-year compliance period," McNeil maintained. "In addition, a one-year compliance period would not provide adequate lead time to redesign potentially non-complying packaging, test new designs and re-tool packaging component production molds," McNeil argued. Suggestions for alternative effective dates ranged from 18 months, offered by Procter & Gamble, to Hoechst-Roussel's recommendation of "at least 2-1/2 years" after the final rule is issued.

Several commenters, including McNeil, Miles Labs and P&G, suggested that CPSC "grandfather" current packaging on the market and require only new packaging to comply with the revised CRP protocol.

"Given the dynamics of the market, wherein the competition for developing new packaging is keen, a decision to grant 'grandfather' status for existing packaging would appear reasonable," Miles asserted.

A plan to allow compliance in phases was urged by a number of commenters. CMA proposed that, if a final rule is issued, CPSC could phase in the "applicability of the new testing protocol by product category, based on the degree of risk of ingestion associated with the product category" and "the pattern of use of the product category."

Noting that "there are a number of issues that are unique to the pharmaceutical industry," Lederle requested that CPSC implement the rule in phases "to allow Lederle and other pharmaceutical companies sufficient time to comply with mandatory FDA rules for all our products." Specifically, Lederle recommended that "the prescription drug category could...be required to comply after [about 18 months following publication of a final rule], while OTC analgesics and iron-containing vitamins, and/or other product categories, could comply at an earlier date."

ASTM suggested that "CPSC could give all manufacturers of OTC analgesics one year to comply, and phase in other product categories at 18 months and two years....This would help alleviate the strain on both the limited testing agency resources and manufacturing resources, and result in an orderly conversion to senior adult-accessible packaging." P&G went a step further, recommending "that CPSC consider separate regulation of health care and non-health care consumer products."